THE RELATIVE EFFECTIVENESS OF A CONSERVATiVE MULTI-METHOD TREATMENT PROTOCOL (S.M. T. AND DICLOFENAC)

FOR THE MANAGEMENT OFCHRONIC MECHANICAL THORACIC SPINE PAIN

BY

NAYNA RATILAL BHOOLA

A dissertation presented to the Faculty of Health in partial compliance with therequirements for the Master's Degree in Technology: Chiropractic.

I, Nayna Ratilal Bhoola do declare that this dissertation is representative of my ownwork.

Signed: _ Date. 17isjo i

Approved for final submission

Dr. H.M. Kretzmann (M.Dip. CnmO:PRACTIC)(C.C.F.C. SA)

Supervisor

Signed. Date: /7-05 -(;).CXJ (

])]EIHCA T!ON

This work is dedicated to His Divine Holiness, Pramukh Swami Maharaj, my constant

source of inspiration, and to my beloved late father, Ratilal Bhoola, you will always be

cherished in my heart. I miss you so much.

To my grandmother, mother Indira and sister Heena, my pillars of strength. I never would

have made it without you. I love you all very much.

11

ACKNOWLEDGEMENTSI would like to thank the following people for their assistance in the compilation of this

study: -

Dr. Heidi Kretzmann, my supervisor, for your time, guidance and expertise.

Dr. Devan Moodley, for your medical expertise.

Mr. Kavanal Thomas, for assistance with the statistical analysis.

Dr. Megan Govender, for assistance with the editing.

Novartis for sponsoring the medication.

The clinic staff: Pat, Linda and Mrs. Ireland.

To my brothers, Jayant and Sanesh, for all your time and help.

To all the patients who volunteered to participate in this research study, without whom

none of this would have been possible.

Above all, thank you GOD for your grace, love and mercy, throughout all my years of

study, you kept me strong.

(Plaugher, G. 1993) J

ran September 18, 1895, Harvey Lillard called upon me. He was so deaffor seventeen

years that he could not hear the noises on the street. Mr. Lillard informed me that he was-

in a cramped position andfeit something give in his back. 1replaced the displaced 4th

dorsal vertebra by one move, which restored his hearing fully.

DR. D.D.PALMER

The Science, Art, and Philosophy of Chiropractic

1910

111

ABSTRACT

The aim of this study was to determine the relative effectiveness of the combination of

spinal manipulative therapy (SMT) and non-steroidal anti-inflammatory drugs (NSAIDs)

versus SMT with the administration of a placebo medication in the treatment of chronic

mechanical thoracic facet syndrome. It was hypothesised that SMT and NSAIDs over a

three week period would be more effective than SMT and placebo medication in terms of

the objective and subjective clinical findings.

The study design was that of a double blind randomized clinical trial. Sixty patients

diagnosed with thoracic facet syndrome were randomly assigned to either the

manipulation and NSAID group or the manipulation and placebo medication group. The

age range of the patients was eighteen to fifty-nine years. Each patient in the NSAID

group received 139mg of diclofenac free acid per day over five days. The placebo group

received the same dosage of a similar appearance to that of diclofenac free acid over the

same period. The placebo medication was in the form of lactose powders. Each group of

thirty patients received six treatments of SMT over a three-week period. Group A

received SMT and placebo medication while Group B received SMT and NSAIDs.

The patients were assessed by means of obtaining subjective information consisting of

three questionnaires; the McGill Short-Form Pain Questionnaire, the Numerical Pain

Rating Scale -lOl and the Oswestry Pain Disability Index. Objective data was gathered

from goniometer measurements. The objective data was collected before the

IV

Intra-group comparison of the results showed that only Group B (the NSAID group)

showed significant (p<0.025) improvements between the first and sixth treatments with

respect to the Oswestry Pain Disability Questionnaire and the Short-Form McGill Pain

Questionnaire. Inter-group comparison of the results showed that there was no significant

difference in the efficacy of the two treatment protocols in terms of objective and

subjective clinical findings. In conclusion, it was found that SMT used in combination

with NSAIDs was as effective as SMT alone in the treatment of chronic mechanical

thoracic facet syndrome. It was recommended that this study be repeated with a more

homogenous sample population. Different studies using different NSAIDs for a longer

period of time would be warranted as individual response may vary according to the type

and duration ofNSAID used.

commencement of the first, third and sixth treatments while the subjective data was

collected at the first and sixth treatment respectively.

The data was transferred to spreadsheets and underwent statistical analysis. The Paired t-

tests were conducted in order to determine whether there was any significant change

within each respective treatment group (intra-group analysis). The Unpaired t-tests were

conducted in order to determine whether there was any significant change between the

two groups (inter-group analysis). The two-sample unpaired t-tests were used to compare

two independent samples with respect to each continuous variable while the two-sample

Paired t-tests were used to compare results from related samples with regards to

continuous variables. The alpha level was set at the 0.05 level of confidence.

v

XIV

TABLE OlF CONTENTS

ABSTRACT

LIST OF TABLES

LIST OF FIGURES

DEFINITION OF TERMS

IV

Xl

Xlll

CHAPTER ONE

1.0 INTRODUCTION

1.1 STATEMENT OF THE PROBLEM

1.2 HYPOTHESIS

1

2.3.1 Definition

2.3.2 Aetiology

2.3.3 Diagnostic Criteria

2.3.4 Anatomy

2.3.5 Evidence of Inflammation

2.4 MANIPULATION

2.4. 1 Definition

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8

10

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3

3

CHAPTER TWO

2.0 REVIEW OF THE RELATED LITERATURE 4

2.1 INTRODUCTION 4

2.2 PREVALENCE AND INCIDENCE OF THORACIC PAIN 4

2.3 FACET SYNDROME 6

VI

vn

2.4.2 Contra-indications

2.4.3 Effects of manipulation

2.4.4 Safety of manipulation in the Thoracic Spine

2.4.5 Motion Palpation ofthe Thoracic Spine

14

15

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17

2.5 NON-STEROIDAL ANTI-INFLAMMATORY DRUGS

2.5.1 Introduction

2.5.2 Diclofenac

2.5.2.1 Mechanism of Action

2.5.2.2 Pharmacological Properties

2.5.2.3 Indications and Therapeutic Uses

2.5.2.4 Toxic Effects

2.5.2.5 Efficacy ofDiclofenac

2.5.2.6 Safety

2.6 CONCLUSION

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24

ClHIAPTlElR T]8[RJElE

3.0 MATERIALS AND METHODS

3.1 INTRODUCTION

3.2THEDATA

3.2.1 The Primary Data

3.2.2 The Secondary Data

3.3 THE SUBJECTS

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27

Vlll

3.4 INCLUSION AND EXCLUSION CRITERlA

3.5 ETHICS

3.6 THE SAMPLE GROUP

3.7 ASSESSMENTS

3.8 INTERVENTIONS

3.8.1 Spinal Manipulative Therapy

3.8.2 Medication

3.9 MEASUREMENTS

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30

3.9.1 Objective Measurements

3.9. 1.1 Goniometer

3.9.2 Subjective Measurements

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32

34

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34

3.9.2.1 Oswestry Back Pain Disability Questionnaire 34

3.9.2.2 McGill Short Form Pain Questionnaire 35

3.9.2.3 Numerical Pain Rating Scale-l0l Questionnaire 35

3.1 0 STATISTICAL PROCEDURES 36

3.10.1 Inter-group Comparison (Experimental versus control) 36

3.10.2 Intra-group Comparison: Experimental 37

3.10.3 Intra-group Comparison: Control 37

3.10.4 Summary Statistics 37

3.10.5 Comparison using bar charts 37

CHAPTlER FOUR

4.0 RESULTS

4.1 INTRODUCTION

4.2 DISCUSSION OF THE RECRUITMENT

4.3 DEMOGRAPI-llC DATA

4.4 THE ANALYSED DATA

39

39

4.4.1 The Inter-group analysis using the t-test

4.4.2 The Intra-group analysis using the Paired t-test

39

40

43

44

49

59

CHAPTlER FNlE

5.0 DISCUSSION OF THE RESULTS

5.1 INTRODUCTION

5.2 INTERGROUP COMPARISON

5.2.1 The Subjective Data

5.2.2 The Objective Data

5.3 INTRAGROUP COMPARISON

5.3.1 The Subjective Data

5.3.2 The Objective Data

5.4 DISCUSSION OF THE DEMOGRAPHIC DAT A

5.5 STUDY LIMITATIONS

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4.5 BAR CHARTS

IX

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CHAPTER S1fX

6.0 RECOMMENDATIONS AND CONCLUSION

6.1 RECOMMENDATIONS

6.2 CONCLUSION

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75

REFERENCES 77

APPEND][X A

APPlENDlIX B

APPEND][X C

APPENDlIX n

APPENDlIX E

AlPPENDlIX F

APPlEND[X G

AlPPENDlIX H

APPENDlIX n

APPENDlIX J

APPENDlIX K

LIST or TABLlES

4.1 Gender Distributions 40

4.2 Age Distributions 40

4.3 Occupation of Patients 4'1

4.4 Distribution of Race 42

4.5 Presence of fixations at the different thoracic spine levels 42

4.6 Comparison of groups A and B using the Unpaired t-test to analyse the 44

results collected from the subjective data at treatment one and six

4.7 Comparison of groups A and B using the Unpaired t-test to analyse the 45

results collected from the objective data at treatment one

4.8 Comparison of groups A and B using the Unpaired t-test to analyse the 46

results collected from the objective data at treatment three

4.9 Comparison of groups A and B using the Unpaired t-test to analyse the 47

results collected from the objective data at treatment six

4.10 Comparison of groups A and B using the Unpaired t-test to analyse the 48

results collected from the Numerical Rating Scale-l0l at treatment one and six

4.11 Comparison of results within group A using the Paired t-test to analyse 49

subjective data collected between treatments one and six

4.12 Comparison of results within group A using the Paired t-test to analyse 50

objective data between treatments one and three

4.13 Comparison of results within group A using the Paired t-test to analyse 51

the objective data between treatments three and six

4.14 Comparison of results within group A using the Paired t-test to analyse 52

XI

xu

the objective data between treatments one and six

4.15 Comparison of results within group A using the Paired t-test to analyse 53

NRS -101 between treatments one and six

4.16 Comparison of results within group B using the Paired t-test to analyse 54

subjective data collected between treatments one and six

4.17 Comparison of results within group B using the Paired t-test to analyse 55

objective data collected between treatments one and three

4.18 Comparison of results within group B using the Paired t-test to analyse 56

objective data collected between treatments three and six

4.19 Comparison of results within group B using the Paired t-test to analyse 57

objective data collected between treatments one and six

4.20 Comparison of results within group B using the Paired t-test to analyse 58

NRS-1 01 collected between treatments one and six

Xlll

]L][ST OlF lFIGURES

4.1 MEDIAN FLEXION VALUES

4.2 MEDIAN EXTENSION VALUES

4.3 MEDIAN RIGHT LATERAL FLEXION VALUES

4.4 MEDIAN LEFT LATERAL FLEXION VALUES

4.5 MEDIAN RIGHT ROTATION VALUES

4.6 MEDIAN LEFT ROTATION VALUES

4.7 MEDIAN OSWESTRY VALUES

4.8 MEDIAN McGILL VALUES

4.9 MEDIAN NRS-lOl VALUES

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XIV

DEFINITION OF TElRMS

CHIROPRACTIC - A discipline of the scientific healing arts concerned with the

pathogenesis, diagnostics, therapeutics and prophylaxis of functional disturbances;

pathomechanical states, pain syndromes, and neurophysiological effects related to the

statics and dynamics of the locomotor system, especially of the spine and pelvis

(Bergmann 1993:756).

MANIPULA TION - Therapeutic application of manual force. Spinal manipulative

therapy (SMT) broadly defined includes all procedures where the hands are used to

mobilize, adjust, manipulate, apply traction, massage, stimulate or otherwise influence

the patient's health (Bergmann 1993:760). For the purpose of this study, the term SMT

will be used to denote the chiropractic spinal adjustment.

ADJUSTMENT-The chiropractic adjustment is a specific form of direct articular

manipulation utilizing either long or short leverage techniques with specific contacts. It is

characterized by a dynamic thrust of controlled velocity, amplitude and direction

(Bergmann 1993: 754).

lFllXATION - The state whereby an articulation has become temporarily immobilized in

a position which it may normally occupy during any phase of physiological movement.

xv

The immobilization of an articulation in a position of movement when the joint is at rest,

or in a position of rest when the joint is in movement (Bergmann 1993:758).

PALPATION - The application of variable manual pressure through the surface of the

body for the purpose of determining the shape, size, consistency, position, inherent

motility, and health of the tissues beneath.

Motion palpation - Palpatory diagnosis of passive and active segmental joint range of

motion.

Static palpation - Palpatory diagnosis of somatic structures in a neutral static motion.

(Bergmann 1993:762)

Jom']"' IDYSFUNCHON - Joint mechanics showing area disturbances of function

without structural change. Subtle joint dysfunction affecting quality and range of joint

motion. It is diagnosed with the aid of motion palpation, and stress and motion

radiography investigation (Bergmann 1993:759).

MYOIFASC][AL TRIGGER POm1!'-A hyperirritable spot, usually within a taut band

of skeletal muscle or in the muscles fascia, that is painful on compression and that can

give rise to characteristic referred pain, tenderness and autonomic phenomena (Bergmann

1993:761).

CHAPTER ONE

1.0 INTlRODUCTION

Although the first successful chiropractic adjustment recorded was in the thoracic spine by D.D.

Palmer in 1910, most of the spinal manipulative therapy (SMT) research has focused on the

lumbar spine (Di Fabio 1992). The thoracic spine has been conspicuously absent from the picture

(Plaugher 1991 :243).

In reviewing the literature relating to the thoracic spine it is apparent that in comparison to the

cervical and lumbar regions, the thoracic region has largely been neglected. This may be

attributed to the technical difficulties associated with movement analysis in this region and the

belief that the thoracic spine is less commonly implicated in clinical pain syndromes (Edmonston

and Singer 1997). Thoracic spine pain plays a much more important role in the differential

diagnosis of chest pain than expected, being third in frequency. Pain of thoracic spine origin can

be easily overlooked and result in a number of false diagnoses and insufficient treatment given

(Bechgaard 1981). Based on epidemiological studies, thoracic spine pain is a common complaint

that can be as disabling as cervical and lumbar pain and deserves wider recognition (Bruckner et

al.1987, Dreyfuss et al.1994, Edmonston and Singer 1997).

The high incidence of chronic spinal pain syndromes, their recurrent nature in many patients, and

their contribution as a main cause of absence from work is well documented (Giles and Muller,

1999). Due to the lack of standardized examinations and optimal diagnostic methods, the tissues

responsible for primary interscapular and atypical chest pain of thoracic spinal origin are poorly

recognized or accepted within the literature (Erwin et al.2000).

1

Worldwide, NSAIDs seem to be one of the most commonly prescribed medications for

musculoskeletal pain (Koes et al. 1997). Jones (1997) postulates NSAID's to be equally effective

as the combination of muscle relaxants and opioids for the control of lower back pain, but

without the possibility of dependence and potential for abuse. This however, for the thoracic

pain, still needs to be determined in a clinical trial.

In pharmacological studies NSAIDs have shown to have anti-inflammatory, analgesic and

antipyretic activity (Arky 1997: 833). The first line of treatment of allopathic physicians for the

treatment of neck pain is usually NSAIDs, whereas the first line of treatment of chiropractic

physicians is usually chiropractic spinal manipulations (Dabbs and Lauretti 1995). The

chiropractic adjustment for a facet syndrome has delivered a high degree of patient satisfaction

when compared to standard medical care (Cherkin and MacCormack 1989).

According to the researcher's knowledge no study existed concerning the treatment of chronic

thoracic facet syndrome with chiropractic manipulation and the use of non-steroidal anti-

inflammatory drugs. This double-blinded, clinical trial was designed to determine whether a

course ofNSAIDs combined with manipulation would result in enhanced recovery of patients

with thoracic facet syndrome compared to those receiving manipulation alone.

The information obtained and the deductions made from the outcome of this study may help to

identify a more effective protocol for treating chronic thoracic facet syndrome.

2

1.1 STATEMENT OF THE PROBLEM

The purpose of this study was to determine the relative effectiveness of the combination of spinal

manipulation used in conjunction with placebo medication as opposed to the combination of

manipulation together with NSAIDs in the treatment of chronic mechanical thoracic spine pain.

SUBPROBLEM ONE

To evaluate the relative effectiveness of chiropractic manipulation used in conjunction with

placebo medication as opposed to manipulation together with non-steroidal anti-inflammatory

drugs in patients with chronic mechanical thoracic pain in terms of subjective clinical findings.

SUBPROBLEM TWO

To evaluate the relative effectiveness of chiropractic manipulation used in conjunction with

placebo medication as opposed to manipulation together with non-steroidal anti-inflammatory

drugs in patients with chronic mechanical thoracic pain in terms of objective clinical findings.

1.2 HYPOTHES][S

NULL HYPOTHESIS

It was hypothesised that chiropractic manipulation combined with non-steroidal anti-

inflammatory drugs will be more effective than SMT with placebo in the management of chronic

thoracic spine pain, in terms of subjective and objective clinical findings.

HYPOTHESIS TWO

Itwas hypothesised that chiropractic manipulation combined with non-steroidal anti-

inflammatory drugs will not be more effective in the management of chronic thoracic spine pain,

in terms of subjective and objective clinical findings.

3

CHAPTER TWO

2.0 REVIEW OF TUIE RlELATED LITERATURE

2.1 INTRODUCTION

This chapter gives a comprehensive overview on the available information on chronic thoracic

facet syndrome as well as on the drug (diclofenac free acid) used in this study. The evidence for

the efficacy of spinal manipulative therapy and the effects it has on the thoracic spine is

presented. NSAIDs, their safety and uses are also discussed.

2.2 THE PREVALENClE AND lrNCIDENCE OF THORACIC SPl[NE PAIN

In the results of a feasibility study on the prevalence of back pain carried out by Triano et al.

(1993) using 186 patients, it was found that thoracic spine pain constituted 13.1% of the

distribution of main complaints, while lumbar spine pain constituted 35.0%, cervical spine pain

18.6% and peripheral joints 6.2%.

Troussier et al. (1994) studied 1178 school children in France in order to determine the

prevalence of back pain. The cumulative prevalence of back pain was 51.2% that is, 36.3% of the

pain was experienced on several occasions, 13.2%ofthe pain was experienced frequently while

1,7% of the pain was experienced continuously. Lumbar pain constituted 41.0% while thoracic

pain accounted for 34.0% of the pain, which was more common than cervical pain, which

constituted 27.0%.

As part of a prospective study of overuse injuries, 395 Israeli male infantry recruits were

evaluated for back pain during a single basic training course. During the course of 14 weeks of

training, 70 recruits (18%) were diagnosed as having overexertional back pain. Thirty-two (8%)

had thoracic pain and forty (10%) had lumbar pain. Two recruits had both lumbar and thoracic

4

pain. In 18 recruits (5%) the pain was paraspinal and in 53 (13%) the pain was elicited over the

spinous processes of both thoracic and lumbar vertebrae (Milgrom et al. 1993).

A study by Fairbank et al. (1984) on 466 pupils aged 13-17 years; found 26% to have a history of

back pain. In 77 of the 115 pupils complaining ofa history of back pain, the anatomic site of

pain was identified where15 had thoracic pain, 24 had thoracolumbar pain, and 38 lumbar pain.

In the USA, a comparative survey between six chiropractic college clinics indicated that the

number of patients seen for lower back pain ranged between 31-41%, neck pain ranged between

19-27% and mid-back pain ranged between 10-15%. Extremity pain constituted 17-22%,

headaches constituted 0-5% while other pain (not stated) constituted 4-14% (Nyiendo et al.

1989).

Bechgaard (1981) investigated the frequency of segmental thoracic pain in 1097 patients

admitted to a medical department and coronary unit complaining of chest pain. A specific

examination of the thoracic spine was performed with minimal risk to possible coronary patients.

Bechgaard found that segmental thoracic pain accounted for 13% of chest pains, making it the

third most common cause of chest pain (behind coronary thrombosis 39%, angina pectoris 20%).

The findings of this study support Gillett's theory in that "the mid-thoracic spine seems to be the

area where most thoracic fixations are found. It is a region that can give much trouble in analysis

and correction because it is the seat of continual recurrent fixations until the focal cause is found

and eliminated" (Gillet 1990).

5

6

According to Grieve (1994) we seem to overlook biomechanical consequences of the anatomical

fact that women have bosoms. He further explains that chronically contracted pectoral soft tissue

and undue tightness of the surrounding thoracic musculature could result in chronically stressed

upper and mid thoracic segments and associated costal joints.

2.3 FACET SYNDROME

2.3.1 Jl)EF:u:N1T1IUN

Facet syndrome may be broadly defined as pain or dysfunction arising primarily from the

zygapophyseal joints and their immediately adjacent soft tissues (Panzer 1995: 415). Gatterman

(1995: Il) defines it as an aggregate of signs and symptoms that relate to the pathophysiology or

dysfunction of spinal motion segments, which is also referred to as the subluxation syndrome.

Bourdillon (1987:54) defines it as an aberrant relationship between two adjacent articular

structures that may have functional or pathological sequelae, causing an alteration in the

biomechanical and/or neurophysiologic reflections of these articular structures, and/or body

systems that may be directly or indirectly affected by them.

2.3.2 AET][OLOGY

Interactions between thoracic spine posture and thoracic mobility are believed to playa role in

the development of spinal pain syndromes (Edmonston and Singer 1997).

A pilot study on 10 healthy subjects done by Harms-Ringdahl and Ekholm (1986) identified a

possible postural cause for thoracic spine pain. Extreme flexion positions of the lower cervical-

7

upper thoracic spine resembling the sitting posture in certain work conditions caused thoracic

spine pain in all 10 experimental subjects within 10 minutes. This pain disappeared within 15

minutes after the end of provocation, but was experienced again by 90% of subjects that same

evening or next morning and lasted up to 4 days. The recorded electromyographic levels from

the splenius, thoracic spinae, rhomboid and lower trapezius muscles also increased during

provocation. Electromyographic activity levels were higher during writing compared to when the

arms were at rest. It was thus concluded that pain does occur in healthy persons in common

work-sitting postures.

Mechanical joint derangement, which forms part of the facet syndrome, may result from acute

injury, repetitive use injury, faulty posture or co-ordination, ageing, congenital or developmental

defects, or other primary disease states that could cause postural disturbances. The inflammatory

component of facet syndrome may be initiated by joint injury, mechanical joint derangement or

joint immobilization (Bergmann et al. 1993: 60).

Panzer (1995: 425) alleges that the occurrence of facet syndrome has been correlated to an

increase in facet weight bearing. Peters (1984) supports this by stating that a history of activity

involving flexion with rotation will put strain on the facet joint. However, he also states that the

cause of facet syndrome is often subtle and that similar symptoms may be produced by forced or

postural hyperextension.

Any degenerative thinning of the inter-vertebral disc results in the superior apophyseal facet

being forced down on the corresponding inferior apophyseal joint surface resulting possibly in

8

an inflammatory reaction and stretching of the joint capsule that is seen in the facet syndrome

(Peters 1984). Mooney and Robertson (1976) hypothesized that trauma may result in entrapment

of the highly innervated synovial villi between the facet surfaces, resulting in irritation of

adjacent nerve roots and therefore pain.

2.3.3 D1lAGNOSTIC CR11'lER1lA

Neck and lower back sprain are diagnoses commonly used by medical practitioners. A similar

pain from the thoracic spine is generally not acknowledged and scarcely mentioned in medical

textbooks and literature (Bechgaard 1981). A misdiagnosis of chest pain can easily happen as it

mimics a diverse number of musculoskeletal conditions, one of which is thoracic spine

dysfunction. A diagnosis of chest pain can cause unnecessary worry when an underlying

biomechanical joint dysfunction goes undiagnosed (Gatterman 1990: 186). Referred pain from

visceral disease is always a cause for concern but may result in repeated misdiagnosis and

mismanagement and even unnecessary surgery (Grieve 1994: 401).

The evaluation of chest pain consumes tremendous amounts of economic and medical resources.

It is usually possible to differentiate cardiac or visceral disorders from musculoskeletal disorders

on the basis of clinical characteristics and a detailed physical exam. The history taking must

focus on location, pattern, character and duration. It is also important to determine exacerbating

and relieving factors as well as associated symptoms of the pain. In conjunction with a detailed

physical examination a meticulous examination of the ribs, spine, sternum and their articulations

will help establish a correct diagnosis. Further diagnostic studies are only necessary when the

origin of the chest pain remains in doubt (Kaye 1993, Fam 1988).

Modifying the acronym PARTS from Bourdillon and Day, Bergmann (1993) identifies the five

diagnostic criteria for the diagnosis of joint dysfunction. The physical signs indicative of joint

dysfunction are pain, abnormalities in alignment, joint mobility and tissue texture.

Pain and tenderness - The perception of pain and tenderness is evaluated in terms of location,

quality and intensity. Most primary musculoskeletal disorders manifest by a painful response.

Pain and tenderness findings are identified through observation, percussion and palpation.

Asymmetry - Asymmetric qualities are noted on a sectional or segmental level. This includes

observation of posture and gait, as well as palpation for misalignment of vertebral segments and

extremity joint structures. Asymmetry is identified through observation (posture and gait

analysis), static palpation, and static radiography.

Range of motion abnormality - Changes in active, passive, and accessory joint motions are

noted. These changes may be reflected by increased, decreased or aberrant motion. It is thought

that a decrease in motion is a common component of joint dysfunction. Range of motion

abnormalities are identified through motion palpation and stress radiography.

Tone, texture and temperature abnormality - Changes in the characteristics of contiguous and

associated soft tissues, including skin, fascia, muscle, and ligaments are noted. Tissue tone,

texture, and/or temperature changes are identified through observation, palpation,

instrumentation, and tests for length and strength.

9

Special tests - Finally, diagnosis may require testing procedures that are specific to a technique

system such as radiographs.

For the purpose of this study, classifications by Triano et al. (1992) were used to diagnose

mechanical spine pain, which does not include pain from a nerve root entrapment or muscular

spme pam.

Mechanical spine pain: -Midline back pain

-Nondermatomal referred pain difficult to localize

-No signs of nerve root tension

-No major neurological deficit

-Pain with compression into spine extension

-Reduced range of motion

2.3.4 ANA l'OMY

In reviewing the literature relating to the vertebral column anatomy and biomechanics it is

apparent that, in comparison to the cervical and lumbar regions, the thoracic spine has been

largely neglected.

Panjabi et al. (1991) studied the three-dimensional surface anatomy on 144 thoracic vertebrae.

The thoracic spine was found to have three distinct regions according to width-to-depth ratios:

upper T 1-T4, middle T4- T911 0, and lower Tl 0-12.The middle thoracic region is characterized by

a relatively narrow end-plate and spinal canal. A small spinal canal makes this region susceptible

to cord impingement, although rib articulations add significant stiffness to the region. This

10

middle region has been called the critical vascular zone, because the blood supply to the spinal

cord is the least profuse at this level.

The kyphotic curve is approximately 46.6 degrees for the entire thoracic spine, that is a vertebral

wedge angle of 3.8 degrees per vertebra (Punjabi et al. 1991). Muscle activation has little effect

on the thoracic kyphosis, which is determined more by the osseous asymmetry of the vertebral

bodies. The thoracic spine kyphosis limits the potential for spinal extension during active and

passive movement (Edmonston and Singer 1997).

Thoracic kyphotic curvature will most certainly influence patterns ofload-bearing and

movement, and the greater the stiffness of the thoracic spine the more it may produce

compensatory changes and pain in the more mobile lordotic regions (Edmonston and Singer

1997). This kyphotic curve makes the thoracic spine more prone to be unstable in flexion (White

and Panjabi 1990:328).

Thoracic disc height, relative to vertebral body height, is less than in the cervical and lumbar

regions and the ratio of disc diameter to height is 2-3 times higher in the thoracic than the lumbar

segments. This reduces the mobility of a functional spinal unit in the thoracic spine (Edmonston

and Singer 1997).

Results obtained from a pilot study by Dreyfuss et al. (1994) indicated that the thoracic

zygapophyseal joints could produce both local and referred pain in a reproducible manner. Nine

asymptomatic volunteers underwent 40 provocative intra-articular injections of the thoracic

11

zygapophyseal joints. The purpose of this study was to isolate and stimulate the thoracic

produced a sensation /pain that was different from the sensation of needle advancement through

zygapophyseal joints via fluoroscopically guided intra-articular injections to determine whether

they were potential pain generators. In this asymptomatic population, 72.5% of the joints injected

the soft tissues. In 27.5% of the joints injected, there was no evoked pain despite adequate

capsular distension. The evoked referral patterns were consistent in all subjects. This study

provided preliminary confirmation that the thoracic zygapophyseal joints can cause both local,and referred pain.

2.3.5 EVIDENCE OF lNFlLAMMATlION

Itwould be pointless to initiate a clinical trial using NSAlDs in the treatment of facet syndrome

if there was no evidence of any associated inflammation. Anderson (1989: 305) defines

inflammation as a 'protective tissue response to injury or destruction of tissues, which serves to

destroy, dilute, or wall-off both the injurious agent and the injured tissues'. Chronic

inflammation is marked chiefly by new tissue formation; it may be a continuation of an acute

form or a prolonged low-grade form.

There is an inflammatory factor in many spinal joint dysfunctions (Bourdillon et al.1992: 283).

This factor is a combination of biochemical and cellular events that is mediated by the vascular

system, but initiated by local events within the affected tissues (Lantz 1995: 163). Bergmann et

al. (1993: 53) include inflammatory response as one of the potential pathological effects of the

facet syndrome. They believe that where pain is a constant feature there must be some degree of

joint or tissue inflammation. Although this is purely an assumption, it stands to reason that there

12

When the cervical spine is injured, the injury results in the release of leucotrienes producing

inflammation, which often leads to the development of trigger points. It is thought that it is this

inflammatory reaction that produces restricted ranges of movement, tendon and fascial

shortening. Presumably this kind of reaction can be inhibited by non-steroidal anti-inflammatory

drugs (Dishman 1988). It is assumed the same would apply to the thoracic spine.

cannot be only one pathological component in facet syndrome. This they explain by including

mechanical and neurobiologic components.

Roy et al. (1988) deduced that inflammation of the joint capsule with subsequent irritation of the

nerve roots was responsible for facet joint pain. Reid (1992: 829) supports this by proposing that

it is these inflammatory flare-ups of facet joint pain and synovitis that produce the facet joint

syndrome. However no literature was found as to the exact cause of these flare-ups. He also

advocates the use ofNSAIDs for the treatment of these flare-ups. To counteract this, Bogduk

(1994: 433) believes that there are mechanical changes and not inflammatory changes that

determine if the zygapophyseal joint becomes symptomatic or not. In a dysfunctional joint, an

inflammatory reaction around a nerve or nerve root may cause persistent pain and often NSAIDs

are preferable to high velocity manipulation (Bourdillon et al. 1992:301,307). They partially

corrected this statement by blaming those who are inexperienced in manipulation in aggravating

the condition, by being too slow, or moving the joint too far and compromising the surrounding

soft tissue, causing further inflammation.

13

14

Mechanical factors, such as decreased movement, may be a result of the primary inflammatory

response, resulting in edema and subsequent pressure on structures primarily concerned with

movement (Gifford 1994: 507,508). Manipulation may aid in the dispersal of edema resulting in

decreased pressure within the joint complex, with a succeeding increase in short-term movement.

2.4. MANlDPULATXON

2.4.1 DEFINITION

According to Brunarski (1984) chiropractic is the principle proponent of spinal manipulative

therapy, while Fitz-Ritson (1987) states that spinal manipulative therapy has been the primary

treatment modality used by the chiropractic profession since its inception.

In chiropractic the term 'manipulation' is used interchangeably with the 'chiropractic

adjustment', and is defined by Mierau et al. (1998) as an abrupt, quick, low-amplitude force

skillfully applied to the apophyseal joints of a specific spinal segment to increase range of

motion in that segment. The manipulative manouver is usually associated with an audible

cracking sound, and it is the joint crack that separates manipulation in general from mobilization.

Haas (1990) however, believes that cavitation is not a necessary criterion to characterize the

completion of an adjustment.

2.4.2 CONTRA-JlNDICATIONS

Accidents that have occurred in SMT appear to have occurred because the diagnosis was in error

or because the manipulative technique used was not accurately applied (Bourdillon et al. 1992:

129, Bergmann et aL 1993: 132).

Patients who have the following conditions should not receive chiropractic manipulation:

Tumours, dislocations, fracture, infection, instability, hematoma, myelopathy, radiculopathy,

congenital anomalies, Arnold Chiari malformation, basilar invagination and cerebral ischemic

syndromes (Wyatt 1992: 199-200). Bourdillon et al. (1992:286) includes osteoporosis and hyper

mobility as contra-indications to manipulation, but Mootz (1995: 180) believes that manipulation

of an unstable segment is unlikely to promote greater instability and may provide the patient with

relief Both authors however, state that the presence of a hyper mobile segment does indicate the

presence of a hypo mobile segment in the vicinity.

It is clear that there are many conditions that are contra-indicated to SMT and that even with all

of its benefits, it is not beneficial to all patients.

2.4.3 lEFFlECfS OF MANllPlULA TION

One of the goals of manipulation is to enable the patient to have maximal pain-free movement of

the musculoskeletal system (Bourdillon et al. 1992: 295). According to numerous authors, the

end result of an adjustment is a joint cavitation with the release of gas from the joint fluid

followed by an increase in range of motion of that joint (Haas 1990, Bergman et al. 1993:140,

Bourdillon et al. 1992:297, Mierau et al. 1988).

Zusman (1994: 651) proposes that structures such as loose bodies, disc material, synovial fringe

or entrapped meniscoid may cause a joint to lock and become fixated, and at the same time cause

stimulation of pain sensitive structures. It is hypothesized that manipulation may free these

15

structures, restoring movement and stopping nociceptive input and associated reflex muscle

spasm (Zusman 1994:651).

A recent study was conducted by Giles and Muller (1999) to compare needle acupuncture,

medication in the form ofNSAIDs (tenoxicam with ranitidine) and spinal manipulation for

managing chronic (>13 weeks) spinal pain syndromes. Seventy-seven patients were recruited for

the study. The study design was that of a prospective, randomized, independently assessed pre-

intervention and post-intervention clinical pilot trial. Results revealed that spinal manipulation

was the only intervention that achieved statistically significant improvement with (1) a reduction

of30.7% on the Oswestry scale, (2) reductions on the visual analogue scale of50.0% for low

back pain, 46.0% for upper back/thoracic pain and 33.0% for neck pain (all p<O.OOl). The

consistency of the results suggests that in patients with chronic spinal pain syndromes, spinal

manipulation, if not contraindicated, results in greater improvement than acupuncture and

medication.

In a pilot study done by Schiller (1999) into the efficacy of spinal manipulative treatment in the

management of mechanical thoracic pain it was found that spinal manipulative therapy had

greater benefits than placebo treatment. The study design was that of a single-blind, randomized,

comparative, controlled pilot study. Thirty subjects were selected from the general population,

diagnosed as having mechanical thoracic spine pain, were randomly divided into two different

treatment groups. Each group consisted of fifteen patients between the ages of sixteen to sixty

years. The research project was carried out where both groups received a maximum of six

treatments over a minimum period of two weeks. Thereafter a one-month follow-up treatment

16

was scheduled to assess the long-term benefits of the two treatments. The study suggested that

SMT may be more effective than placebo therapy in the short-term management of mechanical

thoracic spine pain. Due to the small sample size, the findings of the trial study could not be

considered conclusive, but rather used as a foundation to plan future studies. With the above in

mind the present study included a larger sample size of sixty patients and also aimed at treating

chronic as opposed to acute mechanical thoracic spine pain.

With regards to the effects of manipulation on a patient suffering from facet syndrome, Panzer

(1995:424) proposes the following:

Resultant reduced weight bearing on the posterior facets.

Unlocking of osseous restrictions.

Reduction of local vascular stasis.

Freeing of capsular adhesions.

Breaking of post-immobilization links.

Pain relief by stimulation of certain receptors.

Release of entrapped meniseoids.

2.4.4 SAlFETY OlF MANIlPULA 110N ][N TEE TEOlRAC:n:C SP][NE

According to Bergmann (1993) the main complication from manipulative therapy in the thoracic

spine is rib fracture. Sprain to the costovertebral and costotransverse articulations with

concomitant strain to the intercostals muscles may occur. Additionally, transverse process

fracture and hematomyelia have been identified in rare instances. These problems are usually due

17

to excessive force in relation to the patient's size and physical condition. They can be avoided by

appropriate technique selection and application as well as an adequate evaluation

2.4.5 MOTION PALPATION OlFTHE THORACIC SP][NE

The main purpose of motion palpation is to detect fixation dysfunction. Unless a fracture is

present, an adjustment is not given unless there is a fixation of the motion segment.

Hypermobilities, which appear to be due to direct injury, pathology, or as a compensatory

reaction, are usually indistinguishable from normal segments, unless extreme.

The doctor should motion palpate flexion and extension, lateral flexion, rotation and coupled

extension, lateral flexion, and rotational movements. In flexion and extension, interspinous

separation and approximation are detected. The upper thoracic spine is usually evaluated by

extreme extension of the cervical spine or the patient elevating and crossing the arms and the

examiner raising and lowering them while digitally evaluating the interspinous space closure and

opening. Lateral flexion is palpated by pushing the spinous process opposite from the side of

passive lateral flexion. Rotation and coupled movements are usually determined by applying

digital pressure against the spinous or transverse process (Plaugher 1993 :253).

2.5 NON STEROIDAL ANTI-JlNlFLAMMATORY DRUGS

2.5.1 INTRODUCTION

Worldwide, non-steroidal anti-inflammatory drugs (NSAIDs) seem to be the most commonly

prescribed medications for treating musculoskeletal conditions (Koes et al.1997). Bellamy

(1996) states that NSAIDs are the mainstay of treatment for most musculoskeletal disorders in

18

the western world. They are prescribed extensively for their anti-inflammatory, analgesic and

anti-pyretic properties (Goodman and Simon 1994, Dabbs and Lauretti 1995).

Diclofenac has been established as a leading NSAID in worldwide studies during the past 12

years and has been successfully used for acute as well as chronic or relapsing syndromes marked

by pain and inflammation (Kantor 1986).

Despite their widespread use and perceived safety, NSAIDs have a significant risk of severe

complications. The most frequent and serious adverse effects associated with NSAIDs are

gastrointestinal ulcers and haemorrage (Dabbs and Lauretti 1995).

There are many different NSAIDs available from a variety of chemical classes, including

Aspirin, Mefenamic acid, Tolmetin, Diclofenac, Ibuprofen and Piroxicam, to name but a few

(DiPiro et al. 1989).

The NSAID used in this study was Diclofenac free acid 46.5mg (equivalent to 50mg diclofenac

sodium) under the propriety name Cataflam D Dispersible Tablets.

2.5.2 nIClLOlFlENAC

Diclofenac is the first series ofphenlyacetic acid derivatives that have been developed as anti-

inflammatory agents (Goodman Gilman et a1.1990: 669). It designated chemically as 2-[2.6-

dichlorophenyl amino] benzeneacetic acid, monosodium or monopotassium salt (Arky

1997:833).

19

20

In clinical conditions marked by acute or chronic pain and inflammation, diclofenac sodium has

shown to be an effective anti-inflammatory and analgesic agent (Kantor 1986).

2.5.2.1 MECHAN][SM OF ACT][ON

NSAIDs inhibit the synthesis of prostaglandins and thus act as mediators of inflammation. The

prostaglandins responsible are prostaglandins h and E2, which are formed as end products of the

transformation of arachidonic acid. These prostaglandins are prime peripheral pain receptor sites

for further action by histamine and bradykinin. The result of the interaction between

prostaglandins and bradykinins or histamines in subcutaneous muscle tissue is immediate pain

and inflammation. NSAIDs inhibit the action of prostaglandin synthesis, an intermediary in the

transformation of arachidonic acid to prostaglandins (Kantor 1986).

2.5.2.2 lPlElfAIRMACOlLOG][CAlL lPlROlPlERTlliS

Diclofenac possesses analgesic, antipyretic and anti-inflammatory activities (Goodman Gilman

et al. 1990: 669, Arky 1995:833). Although the exact mechanism of action is unknown (DiPiro

1989:908, Arky 1995:83), the postulated mechanism is that it is an inhibitor of cyclooxygenase

(Goodman Gilman et al. 1990: 669).

Cyclooxygenase is the enzyme that catalyses the synthesis of cyclic endoperoxidases from

arachidonic acid to form prostaglandins. Each respective NSAID varies in its ability to inhibit

cyclooxygenase, however the degree of cyclooxygenase inhibition has not been correlated with

anti-inflammatory efficacy in individual patients (Goodman and Simon 1994).

TECH

All NSAIDs appear to be absorbed completely, are highly protein bound to albumin (>90%;

99,7% for diclofenac) and have low volumes of distribution. Only 5% of the unchanged drug is

excreted in the urine and the bile (DiPiro 1989: 908). The half-lives after single doses vary

greatly and are the most variable property of the various NSAIDs. The anti-inflammatory effect

generally peaks after 2-3 weeks irrespective of the half-life. However, once a steady state is

achieved, saturation of the metabolic pathways increases the halflife (DiPiro 1989:908-909,

Arky 1995:834, Goodman Gilman et al. 1990: 669, Goodman and Simon 1994).

All NSAIDs appear to be as effective as aspirin in terms of analgesic and anti-inflammatory

properties but have shown to cause fewer side effects than aspirin and diclofenac does provide a

longer period of analgesia (DiPiro 1989: 908, Arky 1997: 834). NSAIDs penetrate the joint fluid

in concentrations generall y half those found in the blood (DiPiro 1989:908). Diclofenac

accumulates in synovial fluid after administration, which may explain the duration of the

therapeutic effect that is, considerably longer than the plasma half-life (Goodman Gilman et

a1.l990: 669). This makes it an excellent choice for the treatment offacet syndrome since it is

available within the joint for maximum effect.

2.5.2.3 INDICA 'n:ONS AND THERAlP1EU11C USES

Diclofenac is indicated for the acute and chronic treatment of signs and symptoms of

osteoarthritis and rheumatoid arthritis (Arky 1997:834). It may be useful for short-term treatment

ofmusculo-skeletal injury (Goodman Gilman et a1.l990: 669).

Koes et al. (1997), in their review of randomized clinical trials (n=26) on the efficacy ofNSAIDs

for low back pain, concluded that NSAIDs are effective for short term symptomatic relief in

21

patients with uncomplicated low back pain, but are less effective in patients who are suffering

from back pain and nerve root symptoms respectively.

2.5.204 TOX:n:C EFFECTS

Diclofenac produces side-effects in approximately 20% of patients with about 2% of patients

stopping therapy as a result (Goodman Gilman 1990:669). Gastrointestinal

symptoms such as indigestion, nausea and dyspepsia are the most common side-effects

associated with diclofenac (Goodman and Simon 1994). In extreme cases, (bleeding and

ulceration or perforation of the intestinal wall may occur (Goodman Gilman et al. 1990:669).

Other side-effects as a result of diclofenac administration include central nervous system effects,

disturbances of vision, skin rashes, edema and fluid retention, renal function impairment,

hepatitis, allergic reactions, aplastic anemia and cardio-vascular problems (Cataflam D package

insert: Appendix L).

2.5.2.5 E]F]FICACY OF IIHCLOFENAC

According to Goodman Gilman et al. (1990:669) the potency of diclofenac appears to be

substantially greater than that of indomethacin, naproxen, or several other agents. In one study of

chronic pain in patients with osteoarthritis (n= 196) diclofenac SOmgwas comparable in efficacy

to ibuprofen 800mg (Arky 1997: 834).

In a pharmacy-based survey (n=82) of diclofenac, it was found that the majority of purchases

were for musculoskeletal conditions and headache. Over two-thirds of the respondents (71%)

indicated either moderate or complete relief of their symptoms after taking diclofenac. Sixteen

22

percent of the respondents claimed to have experienced adverse reactions from diclofenac usage,

however none of these reactions were severe enough to prompt the user to notify his or her

pharmacist or doctor. Eighty-three percent of the respondents indicated their willingness to use

diclofenac again in the future (Emmerton et al. 1995). When using post-marketing surveillance

research methods it would seem that larger sample sizes would be required (>1000), in order to

accurately determine the information portrayed in this survey. Other factors influencing the

outcome of surveys like this would depend on the quality of data obtained and the efficacy of

administration.

The reason that diclofenac has a prolonged antinociceptive effect when compared to other

NSAIDs is that there is evidence that this agent is transferred across the synovial membrane to

the synovial fluid, from which it is eliminated more gradually than from plasma as compared to

other drugs. It has been suggested that the clearance of diclofenac from synovial fluid to blood

occurs slowly because the drug binds with high affinity to the albumin that is expropriated into

the synovial space in joint disease. Thus, the prolonged effect of diclofenac can be attributed to

the notion that it is more readily retained by the albumin-enriched synovial fluid when compared

to other NSAIDs (Torres-Lopez et al.1997).

It is however difficult to determine which NSAID is superior to the next, because patient

response to the NSAIDs is typically variable and highly individualistic. A patient may respond

well to one drug in a particular chemical class but have little or no benefit from another NSAID

in the same class (Di Piro 1989: 909).

23

In a randomized clinical trial (p<0.05) comparing the effectiveness of diclofenac, chiropractic

manipulation, physiotherapy, bed rest, back school and placebo on low back pain it was found

that in acute patients, chiropractic was the superior regime. In patients with chronic low back

pain it was found that physiotherapy and back school were the treatment that scored the highest

on the mean improvement scale (Postacchini et al. 1988). The above study design correlated with

the present study under investigation in terms of comparing diclofenac and SMT for the

treatment of chronic thoracic spine pain.

2.6.2.6 SAlFETY

The use ofNSAIDs is associated with a 2% to 4% annual incidence of serious gastrointestinal

complications (Goldstein et al. 1997). Although this incidence is low, the widespread use of

these drugs and the fact that patients may suffer major morbidity or mortality means that the

possibility of side effects must be taken seriously and looked for (Goodman and Simon 1994).

Case control studies suggest that a fifth of all admissions to hospitals in patients over the age of

60 with bleeding gastric or duodenal ulcers is directly attributable to the long term use of

NSAIDs (Edwards and Bouchier 1992: 773). It is estimated that, at any given time, the chance of

a patient on NSAID therapy having a gastric ulcer is 10% to 20%, a rate 5 to 10 times greater

than non-users (Dabbs and Lauretti 1995).

2.6 CONCLUSION

It may well be argued that patients are put at unnecessary risk when receiving both NSAIDs and

thoracic manipulation for the treatment of thoracic facet syndrome. This is certainly true.

Goodman and Simon (1994) suggest that it is important to be wary of patients who are on non-

24

prescription NSAIDs, who often have not informed their physicians. Emmerton et al. (1995), in

their findings, report that of the people surveyed who purchased diclofenac over the counter,

58.4% were using it for the relief of musculoskeletal pain. Chiropractic has become synonymous

with the treatment of musculoskeletal treatment (Haldeman 1992). It seems logical that those

who primarily treat musculoskeletal conditions should have some control over NSAID

administration to patients. This could ensure proper screening of potential users, and thereby

decreasing the possibility ofNSAID abuse by nonprescription users (Goodman and Simon

1994).

Perhaps a study of this nature is premature by combining two treatment protocols together for the

treatment of thoracic pain. Some may argue that we should rather endeavor to find better

chiropractic techniques for the treatment of thoracic pain, instead of leaning on allopathic

medicine for the answers. Perhaps chiropractic research should also rather focus on the

justification and efficacy of chiropractic care.

However, according to Haldeman (1992), medical and chiropractic researchers should no longer

work in isolation. Controlled trials of various medical and chiropractic treatment approaches are

going to have to increase so that decisions can be reached as to when medical intervention is

appropriate and when it is not. With the uprising cost of medication, chiropractic treatment may

prove to be more cost-effective in the long-term management of chronic pain. Chiropractic

treatment for pain in the chronic stages would be well supplemented by the use ofNSAID's, for

the benefit of the patient.

25

The fact that chiropractic science has survived in an era of overwhelming dominance of spinal

research by medical scientists, which is of worldwide acceptance, is a tribute to the chiropractic

profession (Haldeman 1992).

26

CHAPTER THREE

3.0 MATElRIALS AND METHODS

3.]. ][NTlRODUCTION

This chapter gives a detailed description of the design, primary and secondary data, the subjects

and intervention utilized. An overview of each questionnaire used and the validity of each

rneasurement parameter are discussed. The methods used for statistical analysis and the process

in which the data was evaluated is also included.

The study design chosen was that of a double blind, comparative, clinical trial. This involved two

treatment groups, with both groups receiving chiropractic manipulation and each group receiving

either NSAID's or placebo medication respectively.

3.2 mE DATA

The data consisted of primary and secondary data.

3.2.:ft. The primary data

The case history, physical examination and thoracic regional examination of the patients

used in this study.

The patient's perception of their disability (Oswestry Back Pain Questionnaire)

(Appendix I).

The patient's perception of the level of their pain (Numerical Pain Rating Scale-l O'l )

(Appendix H).

The patient's perception of the sensory dimension oftheir pain (McGill Short-Form Pain

Questionnaire) (Appendix 1).

27

The range of motion in the thoracic spine was measured with a goniometer (Brom II).

3.2.2 Tine secoadary Data

Relevant literature was obtained from various sources, including journal articles, books,

pharmaceutical research, Medline, Mantis, the Internet and its relevant search engines.

3.3 THE SUBJECTS

The patients were invited to participate in the research study by means of advertisements placed

on notice boards in gyms, corporate offices and tertiary institutions in the greater Durban area.

Sixty patients were selected from those who responded and randomly assigned to either Group A

or Group B. No bias was given to gender, racial group, occupation or economic status of the

patient.

Each research patient who presented to the Technikon Natal Chiropractic Clinic with chronic

mid-back pain was given a brief assessment to determine if they would be a suitable candidate

for the study. This assessment consisted of questions pertaining to the nature and progression of

the pain and the presence of any hard neurological signs and symptoms as contained in Appendix

A.

If the patient was deemed likely by the researcher to meet criteria necessary for acceptance into

the study, he or she underwent a case history (Appendix E), physical examination (Appendix F)

and a thoracic spine regional examination (Appendix G).

28

3.4 lINClL1USION AND EXCL1USION Cru1'EllUA

The criteria were as follows:

Only patients between the ages of sixteen to sixty were included.

Only patients diagnosed by the researcher as having mechanical thoracic spine pain were

included in the study.

From the case history, physical examination, thoracic regional examination the patients

had to meet the criteria necessary for a diagnosis of thoracic facet syndrome as advocated

by Schafer and Faye (1990:150-159) and Bergmann et al. (1993:63).

o Pain or tenderness over the involved osseous and soft tissue areas,

o Asymmetry/misalignment qualities identified through observation and static

palpation,

o Range of motion restriction identified actively and through motion palpation,

o Palpable tissue tone differences over the area of dysfunction,

o Special tests that include a positive Kemps test and facet joint challenge, done

at the level of dysfunction.

Using motion palpation a thoracic fixation was found in one or more directions for

inclusion of the subjects into the study.

Patients were asked to refrain from taking analgesics and receiving other treatment for

their condition or any other co-existing condition during the research period. They were

asked to inform the researcher if this was the case.

Those patients with active or latent myofascial trigger points were not excluded from the

study.

29

Any condition that contra-indicated NSAID administration resulted in the patient being

excluded from the study.

Patients taking aspirin, anti-coagulants, digoxin, methotrexate, cyclosporin, lithium, oral

hypoglycemics, diuretics or Phenobarbital were not included in the study due to the

varied interaction these drugs have with the medication to be used viz. diclofenac (Arky

1997:835-6).

If any patient developed side effects (Arky 1997:836) related to the medication given,

such a patient was excluded from the study.

Patients with osteoporosis, inflammatory arthritides or any condition contra-indicating

spinal manipulation were excluded from the study.

3.5lETHICS

Each patient was required to complete and sign an informed consent form (Appendix B); prior to

the commencement of treatment. Each patient was told the precise nature of the study, including

the possible side effects of manipulation and the NSAID used. They were informed that they had

a 50% chance of receiving placebo or real medication. The patients were free to withdraw from

the study at anytime and for whatever reason they so wished.

3.6 THE SAMPLE GROUP

The sample group consisted of 60 patients that were conveniently selected that conformed to the

admission criteria governing the study, and was randomly divided into 2 groups of30 each. An

objective observer was appointed by the researcher who then conducted the randomization

procedure, as this study was of a double-blind nature. Groups A and B were identified by placing

numbers 1-30 in envelope 1and an equal number of A's and B's in envelope 2. Prior to this, A

30

and B were deemed by the objective observer as either the experimental (NSAID) or control

placebo medication group. As each number was drawn from envelope I a corresponding letter

was drawn from envelope 2. The sequence was then given to the researcher prior to the

commencement of the study. This allowed the researcher to know which sachet (labelled A or B)

to give to each patient. The letter A or B indicating either the NSAID or placebo medication was

inscribed on each set of 30 sachets. The nature of group A or B was withheld from the researcher

by the objective observer until the study was completed.

3.7 ASSESSMENTS

Those patients eligible for the study were required to complete the NRS-lOl (Jensen et al. 1986),

the Short-Form McGill Pain Questionnaire (Melzack 1987) and the Oswestry Back Pain

Disability Questionnaire (Fairbank et al. 1980) at the initial and final treatment. The thoracic

spine range of motion was measured by using a goniometer produced by Performance

Attainment Associates (St. Paul, MN). Measurements were taken prior to the commencement of

the first, third and sixth treatments.

3.8 lIN1r1ERV1ENTIONS

Every patient who qualified to participate in the study received 6 treatments over a period of3

weeks. If the patient became asymptomatic before the final treatment, the patient continued to

be assessed and treated for the remainder of the treatment period.

As it transpired, patients in Group A were treated using SMT and received placebo medication.

Patients in Group B were treated using SMT and received NSAIDs.

31

3.8.1 SlP:n:NAlLMANIDPUlLA T.II:VETll3lElRAJPY

Both treatment groups received standard, manual thrust, chiropractic adjustments to the thoracic

spine. The level and direction of the thrust was chosen according to motion palpation findings.

With all manipulative techniques the joint slack was taken out to the elastic barrier and a high

velocity, low amplitude thrust was delivered at the level, and in the direction, of the loss of joint

motion (fixation).

The manipulations employed were diversified techniques according to the "Compendium of

Chiropractic Technique" (Szaraz 1990: 96,98, 102, 103).

HYlPOTJl3[]ENAlR TmENAlR TRANSVERSE (Szaraz 1990)

This technique is indicated for either extension or rotation dysfunctions from TI-TI2.The patient

is prone lying with headpiece adjusted in neutral. Contact with the hypothenar eminence is made

with the caudad hand by the doctor on the side of the lesion. Contact hand is against the facet

joint or transverse process while the indifferent hand is placed on the contra lateral TVP of the

same vertebra. Line of drive is posterior to anterior. A body drop thrust is applied at the point of

joint resistance.

CROSSKID>BillLA nAAI.. (Szaraz 1990)

This technique is used for rotation type dysfunctions of T4-T 12. The patient lies prone with the

doctor on the side of the lesion facing cephalad. The final position for the doctor's torso is

determined by the level of the lesion and the patient's dorsal curve. A pisiform contact onto the

ipsilateral TVP is taken up. The indifferent hand (superior hand) is crossed over the contact hand

and placed on the contralateral TVP. Joint and soft tissue slack is taken up in a cephalad

32

direction with the contact hand. A single, high velocity body drop type thrust in a cephalad

direction along the facet facings is executed.

STlERNAL S]PlINOUS S1I'ANlInNG OR SEATED (Szaraz 1990)

This technique is indicated for extension, rotation or lateral flexion fixations. The patient is

standing or seated with arms crossed, neck and upper thoracic spine is flexed. Doctor stands

behind the patient. A sternal contact onto the tip of the fixated spinous process is taken up by the

doctor. Both hands of the doctor wrap around the patient and contract their folded arms. Thrust is

inferior to superior and posterior to anterior. Patient is positioned into the direction of the

fixation i.e. with extension fixation, the patient is positioned in extension. Joint slack is taken out

till resistance is felt and a thrust with the sternum is applied by the doctor, hyper extending his

thoracic spine .

. ANT:JElR1IOR SUlPlI.NE F:n:ST (Szaraz 1990)

This technique is indicated for extension fixations. The patient is supine with the arms crossed

over the chest. The doctor assumes a lunge position facing cephalad. A fist contact is taken with

the knuckles on one side of the spinous process and the thenar on the other side. Thrust is

inferior to superior with the fist as you thrust from anterior to posterior on the chest. The patient

is positioned in extension with the head and neck extended. Joint slack is taken out till resistance

is felt and a body drop thrust is applied through the arms.

33

3.8.2 MEDICA nON

The NSAID used in this study was a diclofenac-based preparation(diclofenac acid-free 46.5mg

equivalent to diclofenac sodium 50mg) with the trade name of Cataflam, which was used for the

following reasons (Arky 1997:833) :

-Measurable plasma levels are observed within 10 minutes of dosing with peak plasma levels

occurring in one hour.

Cataflam diffuses into and out of synovial fluid.

Cataflam comes in convenient blister packs and can be taken on an empty stomach or

with food, which can improve patient compliance.

In one study of chronic pain, in patients with osteoarthritis (N= 196), Cataflam was

comparable in efficacy to ibuprofen 800mg and diclofenac delayed-release tablets 50mg.

Novartis, the pharmaceutical company that manufactures the product, kindly agreed to

sponsor the medication for this trial.

It is classed as a NSAID and is a freely available over the counter drug.

The NSAID tablets were individually crushed using a pestle and mortar and placed in identical

empty paper sachets. The placebo medication consisted of lactose powder with a pinch of salt

added to make the taste somewhat similar to the NSAID being used. The placebo medication was

then also placed in the same type of sachets the NSAID medication was contained in.

The dosage for patients in the experimental group was 139.5mg per day (three crushed tablets) of

Cataflam over five days. Each daily dosage was taken in three separate doses at equally spaced

intervals. Patients in the placebo group took the same number of sachets and for the same

duration as those in the experimental group. Each patient was required to complete a medication

diary (Appendix M).

34

3.9 MEASUREMEN1'S

3.9.], OBJEC1'lME M:JEASl.JlREMEN1'S

The objective data was obtained by means of a goniometer. The readings were taken before the

commencement of the first, third and sixth treatments and was recorded on the form provided

(Appendix K).

3.9.]..]. 1'lIneGonieeneter

The BROM IIproduced by Performance Attainment Associates (St. Paul, MN) was used to

measure thoracic ranges of motion in flexion, extension, bilateral rotation and bilateral lateral

flexion. The ranges of motion were measured in degrees according to the protocol laid out in the

manufacturers procedure manual. The BROM IIwas found to be a reliable instrument in the

measurement of mobility in forward flexion and lateral flexion of the lumbar spine, in a study

conducted by Breum et al. (1995) using 47 asymptomatic subjects. Rotation and extension

received less support. Although, for the purpose of this study BROM IIwas used to measure

movement in the thoracic spine, subsequent movement in the lumbar spine cannot be

overlooked.

3.9.2. SUBJECTIV:JE M:JEAS1UlR:JEM:JEN1'S

3.9.2.1 Oswestry Back Pain Disabihty Questionnaire (Fairbanks et al.1980)

This questionnaire indicates how their pain affects the everyday life of the patient. It determines

the amount of disability experienced by the patient.Triano et al. (1993) used 145 patients to test-

retest the reliability and validity of six questionnaires. Overall, the Oswestry and Visual

35

Analogue pain scale were both more reliable and valid than other questionnaires. They were also

the most responsive to clinical change for musculoskeletal disorders. Fairbanks et al. (1980) in a

group of25 patients found this questionnaire to be a valid and reliable indicator of the disability

experienced by the patient.

The patient answers 10 sections, each with 6 questions on the Oswestry questionnaire. Each

question scores a maximum of 5 points and a minimum of O.The total score is therefore out of

50 and is represented as a percentage disability. This percentage was recorded for statistical

analysis.

3.9.2.2 McGinn Short-Form Pain Questionnaire (Melzack 1987)

The McGill Short-Form Questionnaire (Melzack 1987) is a subjective questionnaire that pertains

specifically to the sensory and affective dimensions of pain. It is used to measure the extent of

pain experienced by the patient. The questionnaire is divided into two sections. Questions 1-11

represent sensory dimension of pain and question 12-15 represents the affective dimension; it

assesses the behavioral and emotional aspects of pain. Each adjective was ranked on an intensity

scale of: - O=none, 1=rnild, 2=moderate, 3=severe. The sum of all the completed sections were

calculated and given a percentage of the highest possible score. Ifall sections were completed

the highest possible score was forty-five and decreased by three for each section not completed.

3.9.2.3 Nnnmmerican]Pain lRatnng Scalle-UH Questionnaire (Jensen et al. 1986)

This questionnaire is extremely simple to administer (written or verbal) and score, it assesses

with ease the patient's perceived level of pain intensity. Jensen et al. (1986) established its

36

validity and reliability when providing subjective information about pain levels. The NRS-lOl

consists of asking the patient to rate theirperceived level of pain intensity on a numerical scale

from 0-100, with 0 being no pain and 100 being the worst pain. The patient indicates by means

of a percentage on a IOcm line, when the pain was at its worst and again when it was at its least.

The average pain intensity was calculated by adding the percentages representing the worst pain

and the least pain and then dividing the total by two. The average pain intensity values were then

used for statistical analysis.

3.10 STA 1['][STICAL lPR.OClEll)"[JRlES

The Statistical Package for the Social Sciences, SPSS, (version 9.0) was used for data entering

analysis.

3.10.1 Inter-group comparison [experimental versus control)

Since the sample size was large (n ~ 30) the t-test was used to compare groups A and B with

respect to each variable of interest. In each test, the null hypothesis states that there is no

.difference between groups A and B with respect to the variable under consideration, at the

a=0.05 level of significance. The alternative hypothesis is that there is a difference.

The decision rule: The null hypothesis is rejected at the a level of significance if p < al2 where

p is the observed level of significance or P-value. Otherwise, the null hypothesis is accepted at

the same level.

37

3.10.2 Experimentak intra-group comparison

The paired-t test was used to compare results from related samples in each of the 6 clinical

procedures in the study. In each test, the null hypothesis states that there is no statistically

significant difference between the two related samples being compared, at the a. level of

significance. The alternative hypothesis states that there is a difference.

Decision rule: The null hypothesis is rejected at the a. level of significance ifp < a., where p is

the observed significance level or P-value. Otherwise, the null hypothesis is accepted at the same

level.

3.10.3. Control: intra-group comparison

The procedure in 3.10.2 was repeated within the control group with the same decision rule.

3.10.4 Summary statistics

The summary statistics consisted of medians, averages and variances for each variable of the

study. These results were needed for the construction of bar charts.

3.10.5. Comparison using bar charts

Selected visual summaries of analytical findings were given by the use of bar charts to compare

groups A and B with respect to selected variables of interest. Median readings were used to

construct bar charts.

o

38

CHAPTER fOUR

4.0 THE lRJESUlLTS

4.1 l!NTRODUCTION

This chapter covers the results obtained from the statistical analysis of the subjective and

objective data, for both the control and experimental group.

Control group - manipulation and placebo (Group A)

Experimental group - manipulation and NSAIDs (Group B)

4.2 DISCUSSION OF TIJ3[1ERECRUITM1ENT

A total of seventy-five people were screened, of which sixty were accepted into the study. The

fifteen patients were excluded either because of failure to complete the treatment (8), presence of

urinary infection (1), development of influenza after the 5th treatment (1), adverse reaction to the

medication (5).

39

4.3 DEMOGRA1PIDCDATA

Table 4.1 Gender Distributions:

GENDER GROUP A GROUP ]B TOTAL

MALES 10 (33%) 6 (20%) 16 (27%)

FEMALES 20 (67%) 24 (80%) 44 (73%)

The overall male: female ratio was 4:Il.

TabBe 4.2 Age Distributions:

AGE ]N'fERV ALS GROUP A GROUP]B TOTAL

16-24 10 6 16 (27%)

25-34 8 9 17 (28%)

35-44 2 2 4 (7%)

45-54 8 10 18 (30%)

55-64 2 3 5 (8%)

The average age for group A was 35.2 years.

The average age for group Bwas 37.3 years.

The average age for group A and Bwas 36.2 years.

40

Table 4.3 Occupation of patients

GROUP A N 0/0 Grou.np B N %

2 7 Caterer 1 3

LaundrySupervisor

8 27 Student 8 27

Student1 3 Pharmacist 1 3

Pharmacist1 3 Electrician 1 3

AdministrationOfficer

1 3 Teacher 1 3

Truck Driver2 7 Domestic 1 3

Sales WorkerRepresentative

1 3 Field 1 3

Matron Nurse Marketer1 3 Insurance 1 3

Bank Clerk Consultant1 3 Gymnast 1 3

Staff Nurse1 3 Receptionist 1 3

Librarian1 3 Hairdresser 1 3

Scholar1 3 Retired 1 3

Accountant saleslady1 3 Creche 1 3

Packer Supervisor1 3 Unemployed 1 3

Unemployed2 7 Self- 1 3

Self-employed employed5 17 Housewife 8 27

Housewife

41

TabBe 4.4 Race distributions:

lRACE GROUP A GROUPlB

INDIAN 25 23

BLACK 1 3

wmTE 3 3

COLOURED 1 1

TABLE 4.5 Presence of fixations at the different thoracic spine levels:

THOlRAC]_C SPlINE GROUP A GROUPlB

1LlEVlELSTI-3 10 13

T4-8 29 30

T9-12 4 2

The most prevalent fixation was found to be in extension.

The prone bilateral hypothenar technique was the commonest adjustment technique used.

Of incidental finding, most women with a heavy breast structure seemed to complain of chronic

dull mid-back pain. Two patients from group A and three patients from group B reported having

breast reduction surgery due to their mid-back pain.

42

4.4 THE ANALYSE]!) ]!)ATA

P-VALllJE 0.=0.05

For the one-tailed tests:

Reject Ho ifP~o.

Accept Ho ifP>a.

As 0.=0.05, the P-value must be less than or equal to 0.05 in order to reject Ho.

For the two-tailed tests:

Rejeet Ho if P ~ 0./2

Accept Ho ifP > a./2

P was the observed level of significance

As a./2 = 0.025, the P-value must be less than or equal to 0.025 in order to reject

Ho.

43

4.41.1 The Inter-group analysis using the t- tests:

Table 4.4 ComparisoJll of grolllps A rund ]B usmg timeUnpaired t-test to rumallysethe resunllts

coRRectedfrom the subiective data at treatment ollDeand six

OSWESTRY AN]) McGm QUEST.I[ONNAIlRES

GROUP A GROUP 1B

ME])IAN MEAN S.E. S.D. p- ME])IAN MEAN S.lE. S.]).

VALUE

OSWl 10 11.8 l.56 8.58 0.176 14 14.93 l.66 9.13

McGILLl 6 8.03 l.27 6.97 0.319 4.5 6.40 l.27 5.53

OSW6 2 6.50 l.71 9.40 0.741 4 5.80 l.22 6.71

McGILL6 2 l.56 0.76 4.20 0.085 0 l.56 0.56 3.07

The null hypothesis is accepted for Oswestry Back Pain Questionnaire and Short Form McGill

Pain Questionnaire which indicates that at a. = 0.05 level of significance there was no

statistically significant difference between groups one and two at treatments one and six.

44

1'able 4.5 Comparison of grounps A and .IB unsing ilie lUnpaired i-test to runaJIyse resunBts

collected! from the obDective data at treatment one

1'lREA 1'MlEN1' ONlE

GJROlU)P A G JRolU1P .IB

MlEDiAN MEAN S.lE. S.D. 1P- MlE])iAN MEAN S.lE. S.]).

VALlUlE

FLEX 10 11.2 0.76 4.19 0.771 10 10.83 0.99 5.45

EXT 10 9.0 0.60 3.33 0.870 10 9.00 0.60 3.33

R.LAT.FLEX 20 19.7 1.06 5.81 0.503 20 19.7 1.06 5.81

L.LAT.FLEX 20 20.06 1.02 5.61 0.156 20 20.06 1.02 5.61

R.ROT 20 22.03 1.15 6.34 0.682 20 22.03 1.15 6.34

L.ROT 20 22.0 1.48 8.15 0.307 20 22.00 l.48 8.15

The null hypothesis is accepted for all the thoracic ranges of motion as there were no statistically

significant differences at treatment one for both groups.

45

Tabne 4L6 ComlDarisolln of grounps A all1d lB usill1g the Ulllpaired t-test to allllaByse resuBts

collected from the objective data at treatment three

TlRJEATMENT THlRJEE

GROUIPA GlROmPlB

MEDIAN MEAN S.K S.D. p- MEDIAN MEAN S.lE. S.D.

VALUE

FLEX. 10 11.4 0.58 3.19 0.690 10 11.0 0.80 4.43

EXT. 10 10.0 0.71 3.93 0.854 10 9.86 0.73 4.00

R LAT. FLEX. 20 19.5 0.87 4.76 0.448 20 18.66 0.79 4.34

L.LAT.FLEX. 20 19.6 0.78 4.30 0.329 20 18.53 0.79 4.36

R.ROTN. 20 20.9 1.22 6.72 0.356 20 22.6 1.35 7.39

L.ROTN. 20 19.8 1.09 5.97 0.449 20 21.00 1.13 6.21

The null hypothesis is accepted for all the thoracic ranges of motion as there was no statistically

significant difference at treatment three for both groups.

46

Table 4.7 Comparison of groups A rumdlBILlsingthe Unpaired t-test to anallyse results

collected from the objective data at treatment six

l'lRJEAl'MENl' srx

GlROUlP'A GlROUJPB

MEDIAN MEAN S.E. S.D. .lP'- MEDlIAN MEAN S.E. S.D.

VALIUE

FLEX. 12.5 13.66 1.01 5.56 0.744 15 14.1 0.84 4.64

EXT. 10 10.83 0.73 4.02 0.891 10 11.0 0.73 4.02

R.LAT.FLEX 20 20.00 0.58 3.19 0.700 20 20.3 0.58 3.19

L.LAT.FLEX. 20 19.66 0.79 4.36 0.402 20 20.33 0.58 3.19

R.ROTN. 20 24.00 1.32 7.23 0.986 20 24.00 1.32 7.23

L.ROTN. 20 22.13 1.37 7.54 0.985 20 22.16 1.16 6.39

The null hypothesis is accepted for all thoracic ranges of motion as there was no statistically

significant difference at treatment six for both groups.

47

Table 4.8 Comparisolll of groups A ami B usilllg the U1I1!!>airedi-test to alllalyse results

from the NumericallRating Scale 101 at treatments one rumdsix

NUMEru:CAL lRA'fJING SCALE-lOt

'fREA 'fMENT 1 'fREA 'fMEN'f 6

MEDllAN MEAN S.lE. S.D. ]P- MEDIAN MEAN S.lE. S.D.

VALUE

NRS1 45 43.60 2.08 11.39 0.317 40 40.43 2.34 12.86

NRS6 25 25.43 3.21 17.61 0.393 22.5 21.70 2.84 15.59

The null hypothesis is accepted for the numerical rating scale 101 as there was no statistically

significant difference for both groups at treatment one and six.

48

4.4.2 The Intra-group analysis using tine Paired t-tests:

Table 41.9 Comparison of results witlnilll group A usinngthe Paired t-test to anallyse

sulbiective data conIected Ibetween treatmennt one and six

GROUP A

TREATMENT t TREATMENT 6

MKII:HAN MEAN SJ). S.E. P- ME1DlXAN MEAN SJ!). S.E.

VALUE

OSW 10 11.8 8.58 1.56 0.001 2 6.50 9.40 1.71

SFM 6 8.03 6.97 1.27 0.001 2 3.23 4.20 0.76

The null hypothesis is rejected for Oswestry Back Pain Questionnaire and the Short Form McGill

Questionnaire, which indicate that at the 0.=0.05 level of significance there was a statistically

significant improvement between treatments one and six.

49

Table 4.10 Comparison of results within group A using the Paired t-test to analyse

obiedive data between treatment one ami three

GROUlPA

'flREA 'fMEN'f 1 'flREA 'fMEN'f 3

MlEDJIAN MEAN SJ). S.lE. lP- MEDJIAN MEAN S.D. S.lE.

VALUE

FLEXION 10 11.20 4.19 0.76 0.763 10 11.40 3.19 0.58

EXTENSION 10 9.00 3.33 0.60 0.301 10 9.66 4.34 0.79

RLAT.FLEX 20 19.70 5.81 1.06 0.912 20 19.56 4.76 0.87

L.LAT.FLEX 20 20.06 5.61 1.02 0.735 20 19.63 4.30 0.78

RROTN 20 22.03 6.34 1.15 0.492 20 20.96 6.72 1.22

L.ROTN 20 22.00 8.15 1.48 0.169 20 19.8 5.97 1.09

The null hypothesis is accepted as there was no significant difference between treatment one and

three for thoracic ranges of motion in group one.

50

Table 4.11 Comparison of results within group A unsnngthe Paired t-test to analyse

objective data betweellUtreatment three rumdsix

GROUP A

'fREA 'fMEN'f 3 'fREA 'fMENT 6

MEDJrAN MEAN S.D. S.E. p- MEDlIAN MEAN S.D. S.lE.

VALUE

FLEXION 10 11.40 3.19 0.58 0.053 12.5 13.66 5.56 1.01

EXTENSION 10 9.66 4.34 0.79 0.129 10 10.83 5.26 0.96

R.LAT .FLEX. 20 19.56 4.76 0.87 0.556 20 20.00 3.47 0.63

L.LAT.FLEX. 20 19.63 4.30 0.78 0.967 20 19.66 2.91 0.53

R.ROTN. 20 20.96 6.72 1.22 0.055 20 23.96 7.91 1.44

L.ROTN. 20 19.80 5.97 1.09 0.112 20 22.13 7.54 1.37

The null hypothesis is accepted as there was no significant difference between treatment three

and six for thoracic ranges of motion in group one.

51

Table 4.12 Comparison of results within group A llISilllgthe Paired t-test to analyse

objective data between treatment one am!! six

GROIUPA\

'IREA TMENT 1 TREATMENT6

MEDIAN MEAN S.D. S.K P- MEDIAN MEAN S.D. S.E.

VALUE

FLEXION 10 11.20 4.19 0.76 0.034 12.5 13.66 5.56 1.01

EXTENSION 10 9.00 3.33 0.60 0.032 10 10.83 5.26 0.96

R.LAT.FLEX. 20 19.70 5.81 1.06 0.814 20 20.00 3.47 0.63

L.LAT .FLEX. 20 20.06 5.61 1.02 0.721 20 19.66 2.91 0.53

R.ROTN. 20 22.03 6.34 1.15 0.218 20 23.96 7.91 1.44

L.ROTN. 20 22.00 8.15 1.48 0.938 20 22.13 7.54 1.37

The null hypothesis is rejected at the 0..= 0.05 level of significance for flexion and extension,

therefore demonstrating an improvement between treatment one and six for group A.

The null hypothesis is accepted for right and left lateral flexion and right and left rotation and

therefore there was no difference between treatment one and six for group A.

52

Table 4.13 Comparison of results within group A using tine Paired t-test to analyse

NRS-lOl between treatmellBt one rumdsix

GR.OUP A

TREA TMlENT 1 TREATMENT 6

MEDIAN MEAN S.D. SJE. P- MED:nA.N MlEAN S.D. S.lE.

VALUlE

NRSlOl 45 43.60 11.39 2.08 0.000 25 25.43 17.61 3.21

The null hypothesis is rejected for NRS-lOl, which indicate that at the a=0.05 level of

significance there was a statistically significant objective improvement between treatment one

and six for group 1.

53

Table 4.14 Comparison of results withi.n group lBusing time ]Paired t-test to analyse

sunbiedive data collected between treatmeJlllt oJllleand six

GROUlPlB

TREATMENT ]. TREATMENT6

MEDJrAN MEAN S.D. S.JE:. lP- MlEDJrAN MEAN S.D. S.E.

VALUE

OSW 14 14.93 9.13 1.66 0.000 4 5.8 6.71 1.22

SFM 4.5 6.40 5.53 1.00 0.000 0 1.56 3.07 0.56

The null hypothesis is rejected for the Oswestry Back Pain Questionnaire and Numerical Pain

Rating Scale lOlQuestionnaire, which indicate that at the a.=0. 05 level of significance there was

a statistically significant improvement between treatments one and six for group B.

54

Table 4.15 Comparison of results within group lBusing the Paired a-test to rumalyse

objective data coD.lectedbetween treatmelllt ollleurl three

GlROtJPlB

TlREA l'MENT 1 l'lREA TMENl' 3

MED][A.N MEAN SJ). S.E. P- MED][A.N MEAN S.D. S.E.VALUE

FLEXION 10 10.83 5.45 0.99 0.854 10 11.00 4.43 0.80

EXTENSION 10 9.16 4.44 0.81 0.301 10 9.86 4.00 0.73

R.LAT.FLEX. 20 18.80 4.44 0.81 0.903 20 18.66 4.34 0.79

L.LAT.FLEX. 20 18.03 5.33 0.97 0.612 20 18.53 4.36 0.79

R.ROTN. 20 2l.33 6.81 l.24 0.326 20 22.66 7.39 l.35

L.ROTN. 20 20.13 5.63 l.02 0.489 20 21.00 6.21 l.13

The null hypothesis is accepted, as there was no statistically significant difference for thoracic

ranges of motion in group B.

55

Table 4.16 ComparisoIll of results withilll group JIl using the ]paired t-test to analyse

objective data coInected !between treatmennts three ami six

G1ROU]PJll

T1REATMlENT 3 T1REATMlENT 6

MlEDIAN MEAN S.D. S.lE. ]P- MlEDIAN MlEAN S.D. S.lE.

VALUlE

FLEXION 10 11.00 4.43 0.80 0.000 15 14.11 4.64 0.84

EXTENSION 10 9.86 4.00 0.73 0.141 10 11.00 4.02 0.73

R.LAT.FLEX. 20 18.66 4.34 0.79 0.057 20 20.33 3.19 0.58

L.LAT.FLEX. 20 18.53 4.36 0.79 0.107 20 20.33 3.19 0.58

R.ROTN. 20 22.66 7.39 1.35 0.293 20 24.00 7.23 1.32

L.ROTN. 20 21.00 6.21 1.13 0.409 20 22.16 6.39 1.16

The null hypothesis is rejected at the a=0.05 level of significance for flexion, therefore

demonstrating an improvement between treatment one and three for group B. The null

hypothesis is accepted for extension, right and left lateral flexion, right and left rotation and

therefore there was no significant difference between treatment one and three for group B.

56

Table 4.17 Comparison of results withilll group 1Busing tine Paired! i-test to analyse

o!biectnve data collected !between treatment one 3llld six

GROUPB

TruEA l'MENT 1 TREATMENT 6

MEDlLAN MEAN S.D. S.E. P- MEDlLAN MEAN S.D. S.E.

VALUE'.

FLEXION 10 10.83 5.45 0.99 0.003 15 14.10 4.64 0.84

EXTENSION 10 9.16 4.44 0.81 0.031 10 11.00 4.02 0.73

R.LAT .FLEX. 20 18.88 4.44 0.81 0.086 20 18.80 4.44 0.81

L.LAT .FLEX. 20 18.03 5.33 0.97 0.060 20 20.33 3.19 0.58

R.ROTN. 20 21.33 6.81 1.24 0.103 20 24.00 7.23 1.32

L.ROTN. 20 20.13 5.63 1.02 0.190 20 22.16 6.39 1.16

The null hypothesis is rejected at the 0.=0.05 level of significance for flexion and extension,

therefore demonstrating an improvement between treatment one and six for group B.

The null hypothesis is accepted for right and left lateral flexion, right and left rotation and

therefore there was no difference between treatment one and six for group B.

57

Table 4.18 Comparison of results within group lBusing the lPaired t-test to allUalyse

NRS-lOl collected betweellll treatment one and sn

GROUlPlB

TREA'IMENT 1 'IREA TMENT 6

MEDIAN MEAN S.D. S.lE. lP- MEDIAN MEAN S.D. S.lE.

VAlLUE

NRS10I 40 40.43 12.86 2.34 0.000 22.5 2l.73 15.59 2.84

The null hypothesis is rejected at the a=0.05 level of significance for the Numerical Rating Scale

101, therefore demonstrating an improvement between treatment one and six for group B.

58

4.5 BAR.CHARTS

Figures 4.1-4.9 are visual representations of the median value changes of group A and group B

found within the first, third and sixth consultations. These values are not meant to be used to

draw comparisons between the two groups but are given to show possible trends.

S9

Figure 4.1

MEDIAN FLEXION VALUES

15

10Degrees

5

ovisit 1 visit 3 visit 6

Consultations

[Jill GROUP AIIGROUP B

60

Figure 4.2

MEDIAN EXTENSION VALUES

108 ....6

Degrees 4·

2o

visit 1 visit 3 visit 6Cons uitations

mdGROUP A.GROUP B

61

Figure 4.3

MEDIAN RIGHT ROTATIONVALUES

~GROUP A.GROUP B

62

2015

Degrees 10 .5o

visit 1 visit 3 visit 6

Consultations

Figure 4.4

MEDIAN LEFT ROTATIONVALUES

2015

Degrees 10 .5o ...

visit 1 visit 3 visit 6

Consultations

~GROUPABGROUP B

63

Figure 4.5

MEDIAN RIGHT LATERALFLEXION VALUES

2015

Degrees 105O~' ~

visit 1 visit 3 visit 6

Consultations

ElJGROUP A.GROUP B

64

Figure 4.6

MEDIAN LEFT LATERALFLEXION VALUES

2015

Degrees 105o

~GROUPA.GROUP B

visit t visit 3 visit 6Consultations

65

Figure 4.7

MEDIAN OSWESTRY VALUES

15

10oio Pain

[Gd GROUP A.GROUP B

5

ovisit 1 visit 6

Consultations

66

MEDIAN McGill VALUES

Figure 4.8

40/0 Pain

2

o

6

visit 1 visit 6

Consultations

~GROUPA.GROUP B

67

MEDIAN NRS-101 VALUES

Figure 4.9

5040

Ol p. 3010 am 20

10o

visit 1 visit 6Consultations

~GROUPA.GROUP 8

68

CHAPTER fIVE

Cl8IAlPTlE1R1FlIVE

5.0 DISCUSS][ON OlFTHE lI.UESULTS

5.1 ][NT1ROIDUCTION

This chapter is concerned with the discussion of the objective and subjective data obtained from

the first, third and final treatments.

Objective data: Goniometer

Subjective data: Numerical Pain Rating Scale -101

Short Form McGill Pain Questionnaire

Oswestry Back Pain Disability Index

The results are discussed in two sections :-

Inter-grollllp re8l1RU:s:-

The data from the first consultation from both groups is assessed to determine if there was any

difference between the two groups in terms of signs and symptoms of the presenting condition. It

further provides baseline information as to whether subjects from both groups differed in terms

of the intensity of their pain. A comparison of the sixth consultations for both groups indicates

which treatment regime was more effective.

Intra-grolllp re8ll1lUts:-

The evaluation of the data obtained from the first, third and sixth consultations represent the

"the time response" of the treatment regime. A comparison of the first and sixth consultation

indicates to what extent the clinical condition of the patient has improved.

69

5.2 INTER-GROUP COMPA.lRISON

5.2.1. The Subiective data

The statistical data can be found in table 4.4.0n statistical analysis, no significant differences

could be detected between the two groups at the fust treatment. This suggests that the clinical

picture caused by chronic thoracic facet syndrome was similar between the two groups initially.

Statistical analysis of the Short Form McGill Pain Questionnaire and Oswestry Back Disability

Index revealed no significant difference between the two groups at any period of time throughout

the study. This indicates that both treatment approaches were as effective in the amount of

disability and sensory dimension of pain experienced by the patient.

The median values (refer to figures 4.7-4.9) for both groups do not tend to indicate a similar

response to the respective treatments. The median Oswestry values were lower for group A than

for group B at the final treatment, while the median McGill values for group B far exceeded that

of group A at the final treatment.

5.2.2 The ObBective Data

The statistical data for the thoracic ranges of motion measurements can be found in tables 4.5-

4.8.On statistical analysis, no significant difference could be detected between the two groups at

the first, third and sixth treatments suggesting that both groups were fairly linear. This suggests

that benefits of both treatment protocols are similar. Comparison of the median value changes

showed that group B demonstrated greater movement in flexion than group A at the final

treatment. The median value changes for thoracic ranges of motion (figures 4.1-4.6) for the

70

groups tend to show differences in treatment response at the final treatment, favouring a

combination of SMT with NSAIDS as opposed to SMT alone.

5.3 JINTlRA-GROur COMlPAru:SON

5.3.1 TlhteSubjective IData

The statistical data can be found in table 4.9. Statistical analysis within the NSAID group

revealed a significant improvement for all the subjective measurements taken from the first to the

final treatments. This suggests that SMT combined with NSAIDs is clinically effective for

reduction of disability, percentage pain and sensory dimension of pain for chronic thoracic facet

syndrome.

Within the placebo group, statistical analysis revealed a significant improvement for the

Oswestry Back Disability Index and the Short Form McGill Pain Questionnaire while the

Numerical Rating Scale-IO'l revealed no significant difference.

5.3.2 Tine Objective Data

The statistical data for the thoracic ranges of motion can be found in tables 4.10-4.18.

Group B showed a statistically significant improvement in thoracic ranges of motion especially

in flexion during the period between the first and the sixth, and the third and the sixth treatments

respectively.

In comparison, statistically significant improvement could only be found within the placebo

group in all objective measurements during the period between the first and final treatments

indicating that placebo therapy is effective in improving thoracic ranges of motion.

71

To conclude, the data suggest that NSAIDs and SMT were more effective in terms of mean

improvement per treatment than SMT alone as well as in terms of pain and disability in treating

chronic thoracic facet syndrome.

5.4 DISCUSSION OlF Tm: DlEMOGRAlPIDC DATA

The gender distribution was similar in the two groups with a higher ratio of females (Table 4.1).

Table 4.2 regarding the prevalence of age shows that both groups had a relatively equal

distribution in the 25-34 and 35-44 age group interval. Patient age distribution in Group A was

higher in the 16-24 age group interval, while Group B had a higher distribution in the 45-54 age

group interval. Even with these inequalities, the mean age for each group was similar as seen in

table 4.2.

The occupation ofthe patients are shown in table 4.3.The fact that 50% of the patient

occupations involved sitting, deskwork posture, may give an insight into the types of

musculoskeletal conditions that may prevail as more and more occupations involve deskwork.

5.4 STUDY LIMJ[TATIONS

When comparing the baseline characteristics between the patients in each group, it can be seen

that although the ratio of male to females within each group was unequal, it was comparative

between the two groups. Although not exact, age distribution was relatively the same in each

group. Patient occupations seemed to have varied between the two groups. This may have had an

impact on the study, as some patients may have returned from the treatment to adopt a stressful

72

position related to their occupation, possibly causing their pain and distribution to return

relatively quickly.

The subjective measurements that the patients had to complete were not designed specially for

determining the pain and disability of patients suffering from chronic thoracic facet syndrome or

for the treatment methods used in this trial. It is also possible that some patients may not have

fully understood the method of completing each questionnaire, thus affecting their response

negatively or positively. Some patients may have enhanced their improvement responses so as to

please the researcher.

The objective measurements have the possibility of containing some error due to human

. reliability in taking the readings.

Although every effort was made to ensure all the patients took their medication as prescribed,

this may not have been the case. Patient medication diaries were screened at the first three

consultations, but there is the possibility that this still did not ensure that complete compliance

existed. Patients may have falsely filled in medication times so as not to disappoint the

researcher. One aspect of this research that may well be criticised is that the manipulative

procedures were performed by a student, and not a therapist who had many years of experience.

73

CHAPTERS!X

C.HAPTER S][X

6.0 R.ECOMMEN]!)A l'][ONS AN]!) CONCJLUS][ON

6.1 R.ECOMl\1DEN]I)ATIONS

SAMPLE SIZE:

A larger sample size should have been selected using a stratified random sampling procedure

taking into account age, gender, duration of complaint, location of pain and occupation. These

factors could aid in making the sample more representative of the population and thus produce

more valid trial conclusions.

MEDICATION:

Of concern, when involving medication in a clinical trial, is patient compliance. Therefore future

trials should endeavor to provide a live-in environment for the research patients in order to

ensure that medication, both placebo and experimental is taken timeously and correctly. This

however, would be financially impossible for most research projects.

HOMOGENEITY

Location of pain in the thoracic spine should be taken into account. The study should be limited

to only the middle region of the thoracic spine (T5- T9) due to the differences in anatomy and

biomechanics of the 3 regions (Edmonston and Singer1997); this would allow for greater

accuracy and specification of results.

74

ONE MONTH FOLLOW-UP TREATMENT

In order to determine a long term response to the treatment administered, especially for chronic

pain, it is recommended that a one month follow-up treatment be included in future studies.

ACCURACY OF MEASUREMENTS:

As techniques advance more sensitive instruments should be introduced into clinical trials. This

should allow for more accurate readings and greater detection of small but significant differences

in effects of treatments.

CHILDREN:

It is also recommended that a study investigating the prevalence and incidence of thoracic spine

pain be undertaken in school children as there is increasing evidence that mid-back pain is

common in this age group.

THORACIC MUSCULATURE:

It is also recommended that research into the treatment of myofascial trigger points in the

thoracic musculature together with chiropractic manipulation be investigated thus assessing

treatment for the muscle and joint complex.

75

6.2 CONCLUSION

The results of this study indicate both treatment protocols were effective in treating thoracic facet

syndrome. At a 95% confidence level neither group showed statistically significant intergroup

differences over the other in treatment effectiveness. The median and mean data taken from the

subjective measures did however suggest the possibility that thoracic spine manipulation and

NSAIDs as a treatment protocol may be more effective in relieving pain and disability than

thoracic spine manipulation alone. This is not conclusive, as it does not fit into the statistical

confidence parameter this trial employed, and will only be clarified by future research trials of

this nature.

The use ofNSAIDs combined with manipulation for the treatment of chronic thoracic facet

syndrome may present the consulting doctor with moral and clinical dilemmas. The inclusion of

an allopathic approach into a chiropractic one, may lead to the jeopardy of a distinction the

chiropractic profession as held from other health professions, which has perhaps ensured the

survival of chiropractic over the last 105 years. The decreased prevalence of thoracic pain is

reflected in the paucity of literature regarding the diagnosis and treatment of thoracic spine pain

syndromes. However, this does not negate the importance of managing mid-back pain, which can

be as disabling as cervical and lumbar pain. Will anything be gained by the use ofNSAID's for

the benefit of the patient? Maybe the increased side-effects and increase in deaths (bleeding to

death) will nullify the benefits of minor increased pain relief

In conclusion, this study has demonstrated that the use ofNSAIDs combined with chiropractic

manipulation, is as effective as chiropractic manipulation alone in treating chronic mechanical

thoracic facet syndrome.

76

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86

Appendix A

TECHNIKON NATAL CHIROPRACTIC CLINIC

Chiropractic Research on Chronic 1-'1echanical Thoracic Pain

--Dear Patient

Thank you for considering enrolling in this research programme. Outlined below is abrief explanation of what the research programme entails as well as what would beexpected of you, the patient.

The research project in which you will participate, will endeavour to determine if Non-Steroidal Anti-Inflammatory drugs (NSAlD's) will provide a more effective treatmentprotocol, when combined with manipulation, in treating chronic mechanical thoracic painor mid-back pain. You will be randomly assigned to one of two groups. The first groupwill receive Cataflarn (the NSAlD to be used in this study) and manipulation of the mid-back. The second group will receive a substance that has no medicinal properties andmanipulation of the mid-back. So, as you can see both groups of people will receivechiropractic treatment for their mid-back pain. Neither you, nor I (the researcher) willknow which group you are in.

You will be required to take the medication prescribed to you by Dr. Moodie)' (a medicaldoctor) three times a day for five days. The powder in the sachet must be dissolved inwater and then drunk. Please fill in your medication diary each time you take yourmedication. You will be treated six times over a three-week period. You are expected tobe present at all of these sessions.

If you develop any symptoms during the course of this research project that are notrelated to your existing back complaint, please inform me so that we can make duearrangements to stop your medication and remove you from this clinical trial.

You are please asked not to alter your lifestyle for the sake of this research project. eg. ifyou spend two hours a day typing, continue to do so. You are also asked not to take anyother medication while you are a candidate of this research project as it will alter theoutcome of your treatment.

Please feel free to voice any concerns to me. Thank you for volunteering to participate inthis clinical trial.

Nayna Bhoola(Chiropractic Intern)

INlFOR.MED CONSENT lFORM(To be completed by patient I guardian) Appendix B---._.~-...

Date

Title of research project : The relative ef'fectiveness of a conservative mu.nUi-metll:nmlltreatment protocol (S.M. T. andl Didofenac) for th.emanagement of chron.D.cmecll:nmmicalthOlracic spin.e pain.

Name of supervisor : Dr. Heidli Kretzman.n

Name of research student : NayDa lBhoola

Please circle th.e appropriate an.swer YES NO

1. Have you read the research information sheet? Yes No

2. Have you had an opportunity to ask questions regarding this study? Yes No

3. Have you received satisfactory answers to your questions? Yes No

4. Have you had an opportunity to discuss this study? Yes No

5. Have you received enough information about this study? Yes No

6. Who have you spoken to?7. Do you understand the implications of your involvement in this study? Yes No

8. Do you understand that you are free to withdraw from this study? Yes No

a) at anytimeb) without having to give any a reason for withdrawing, andc) without affectirig your future health care.

9. Do you agree to voluntarily participate in this study Yes No

If you have answered no to any of the above, please obtain the necessary informationbefore signing

Please Print in.bllock lletters:

Patient ISubject Narne: _ Signature: _

Parent IGuardian Narne: _ Signature: _

Witness N arne:------------ Signature: _

Research Student Name: _ Signature: _

Appendix C

INDEl\tINITY

WHERE THlE FOLLOWING REQUIRE SIGNATURES, IT WllL BE TlIlAT OF THE PATIENT IFOVER 21 YEARS OF AGE. OIR BY THlE PATIENT AND PAlRENT IF UNDER 21 YEARS

1. While every effort has been made to screen the patient for possible drug interactions or effects, theresearch team cannot be held responsible for ad hoc reactions that may develop. While all patients may beprotected by common laws , it is also imperative that the patient specifically indemnifies the researchteam, including Doctor D.R MoodIey and Technikon Natal against prospective legal action.

2. Telephonic or other consultations are a necessary part of the research. The patient acknowledges this andmakes no claim against default in such cases

3. Any consultation or special investigation deemed necessary by the research team will be followed by thepatient concerned, failing which the patient is freely entitled to be excluded from the study. This clausedoes not revoke the constitutional rights of the patient in terms of freedom of will.

4. I am prepared to undertake emergency or other treatment at a government hospital hospital should theneed arise. Private or attached costs will not be borne by Technikon Natal, Dr MoodIey or any member of

the research tearn.

SIDE EFFECTS OF ANTI- INFLAMMATORY DRUGS:

1. Gastro-intestinal symptoms including heartburn, acid reflex, indigestion, nausea, vomiting,bleeding, peptic ulcers.

2. Oedema (swelling of body) especially at ankles.3. Transcient hepatitis4. Transcient renal dysfunction5. Skin and allergic reac~ns including urticaria and angiooedema6. Blood disorders e.g.~eamia, decreased platelets, decreased white blood cells7. Wheeze related to bronchoconstriction8. Dizziness and headaches

**1 have been advised of all the above side-effects that can occur in a small minority of patients

**1 will inform the research team should any of the above side-effects develop

PATIENT:

PARENT:

DATE

Appendix D

(B. MedSc. Hons; MEGill) PRACTICE NO : 1565192GENERAL :MEDICAL PRACTITIONER & CLlNICAL ANATOMIST

23 KLAARWATER RDSHALLCROSS4093TEL: 491471FAX: 491371

16 AUTUMN GROVE:M..I\LVERN4093TEL: 4631162CELL: 0824659742

VAT NO : 4560179642

PATIENT PROFn.E AND DRUG INFORMATION SCREENING FOR PROSPECTIVE STIJDllESINVOLVING ANTI-INFLAMMATORY DRUGS AT TECHNIKON NATAL cmROlPlRACTICDEPARTMENT

QUESTIONNAIRE :

1. Have you had any reaction, allergic or otherwise to any inflammatory drug, or drug used in the management of painor musculo-skeletal disorders (e.g. Aspirin, Disprin, Voltaren, Feldene) ?

YESNO

2. Have you ever had any disorder of the liver, biliary tract or pancreas ?

YESNO

3. Have you ever suffered with recurrent heartburn, peptic ulcers, bleeding disorders, including the vomiting of blood orpassage of blood rectally or otherwise ?

YESNO

4. Are you currently taking Warfarin, Aspirin, other anticoegulants or anti-inflammatory agents or any other drug at all,whether allopathic, herbal or otherwise, including steroid based agents ?

YESNO

5. Have you ever suffered any dysfunction of the kidneys, bladder or urinary system ?

YESNO

6. Have you ever suffered from any medical condition not disclosed above

YESNO

DETAllS ~----------

7. Have you bad any surgery previously?

YESNODETAnS _

8. Have you received a blood transfusion in the last 5 years ?

YESNOREASON _

9. Have you bad endoscopy, radiographs or other investigations done to you?

YESNODETAnS, __

10. Are you asthmatic, or do you suffer with chronic disease of the lungs or respiratory system ?

YESNO

YESNO

Il. Have you been diagnosed with any psychiatric disorder including depression, manic depression, or are you on anti-psychotic medication or Lithium therapy

YESNO

FEMALE PATIENTS:

1. Are you pregnant now?

2. State the onset date of your last period. _

3. Are your periods regular ? _

THE ABOVE DETAILS AlRlETRUE TO 1HlE BEST OF MY ABJDLITY_

Patient _,... _ 1D. _

Parentuun~21 _ 1D. _

' ..J

,-' ~'-'''''-''.-._----

~.. TECHNIKON NATAL CHIROPRACTiC DAY CLINICCASE HISTORY

Patient:. _file#:, _Age:, _Intern: _

Sex _

Date: _X-Ray#:. _

Occupation: _Signature: _

FOR CLINICIAN"S USE ONLYInitial visit clinician:. Signature: _

Case History:

Examination:Previous: " Current:

X-Ray Studies:Previous: Current:

Clinical Path. lab:Previous: Current:

Case Status:

PTI: Conditional: Signed Off: Final Sign out:

Recommendations:

Intern's Case History

1. Source of History:

2. Chief Oomplaint (patient's own words)

1

Appendix E

2

3. Present Illness:

.. Location

.. Onset

Duration

.. Frequency

.. Pain (Character)

Progression

.. Aggravating Factors

.. Relieving Factors

.. Associated S s S

.. Previous Occurrences

.. Past Treatment and Outcome

4. Other Complaints:

5. Past Medical History:

.. General Health Status

.. Childhood Illnesses

.. Adult Illnesses

Psychiatric Illnesses

.. Accidents/Injuries

.. Surgery

.. Hospitalizations

7. Immediate Family Medical History:

.. Age.. Health.. Cause of DeathI>- DM.. Heart Disease.. TB.. Stroke.. Kidney Disease.. CA.. Arthritis.. AnaemiaI>- Headaches.. Thyroid Disease.. Epilepsy.. Mental lIIr:tess.. Alcoholism.. Drug Addiction.. Other

3

6: Current health status and life-style:

.. Allergies

Immunizations

.. Screening Tests

Environmental Hazards (Home, School, Work)

I>- Safety Measures (seat belts, condoms)

I>- Exercise and Leisure

I>- Sleep Pattems

.. Diet

Current Medication

I>- Tobacco

.. Alcohol

.. Social Drugs

8. Psychosocial history:

... Home Situation and daily life

... Important experiences

... Religious Beliefs

9. Review of Systems:

... General

... Skin

... Head

... Eyes

Ears .

... Nose/Sinuses

... MouthfThroat

... Neck

... Breasts

... Respiratory

Cardiac

Gastro-intestinal

.. Urinary

Genital

Vascular

... Musculoskeletal

... Neurologic

Haematologie

... Endocrine

Psychiatric

4

Append~.F

IECHNII<O\lINJSJAL' .~

TECHNIKON NATAL CHIROPRACTIC DAY CLINIC

PHYSICAL EXAMINATION

. Patient: File#: Date: _Clinician: Signature: _Intern: Signature: _

1. VITALS

Pulse rate:Respiratory rate:Blood pressure:Temperature:Height:Weight:

R L

2. GENERAL EXAMINATION

General Impression:Skin:Jaundice:Pallor:Clubbing:Cyanosis (Central/Peripheral):Oedema:Lymph nodes - Head and neck:

- Axillary:- Epitrochlear:- Inguinal:

Urinalysis:

3. CARDIOVASCULAR EXAMINATION

1) Is this patient in Cardiac Failure?2) Does this patient have signs of Infective Endocarditis?3) Does this patient have Rheumatic Heart Disease?

Inspection - Scars- Chest deformity:- Precordial bulge:- Neck -JVP:

Palpation: - Apex Beat (character + location):- Right or left ventricular heave:- Epigastric Pulsations:- Palpable P2:- Palpable A2:

· Pulses: - General Impression:- Radio-femoral delay:- Carotid:- Radial:

- Dorsalis pedis:- Posterior tibial:- Popliteal:-Femoral:

Percussion: - borders of heart

Auscultation: - heart valves (mitral, aortic, tricuspid, pulmonary)- Murmurs (timing,systolic/diastolic, site, radiation, grade).

4. RESPIRATORY EXAMINATION

1) Is this patient in Respiratory Distress?

Inspection - Barrel chest:- Pectus carinatum/cavinatum:- Left precordial bulge:- Symmetry of movement:- Scars:

Palpation - Tracheal symmetry:~Tracheal tug:- Thyroid Gland:- Symmetry of movement (ant + post)- Tactile fremitus:

Percussion - Percussion note:- Cardiac dullness:- Liver dullness:

Auscultation - Normal breath sounds bilat.:- Adventitious sounds (crackles, wheezes, crepitations)- Pleural frictional rub:- Vocal resonance - Whispering pectoriloquy:

- Bronchophony:- Egophony:

5. ABDOMINAL EXAMINATION

1) Is this patient in Liver Failure?

Inspection - Shape:- Scars:- Hernias:

Palpation - Superficial:- Deep = Organomegally:

.- Masses (intra- or extramural) ...- Aorta:

Percussion - Rebound tenderness:- Ascites:- Masses:

Auscultation - Bowel sounds:- Arteries (aortic, renal, iliac, femoral, hepatic)

Rectal Examination - Perianal skin:- Sphincter tone & S4 Dermatome:- Obvious masses:- Prostate:- Appendix:

6. G.U.T EXAMINATION

External genitalia:Hernias:Masses:Discharges:

7. NEUROLOGICAL EXAMINATION

Gait and Posture - Abnormalities in gait:- Walking on heels (L4-L5):- Walking on toes (S1-S2):- Rombergs test (Pronator Drift):

Higher Mental Function - Information and Vocabulary:- Calculating ability:- Abstract Thinking:

G.C.S.: - Eyes:- Motor:- Verbal:

Evidence of head trauma:

Evidence of Meningism: - Neck mobility and Brudzinski's sign:- Kernigs sign:

Cranial Nerves:

Any loss of smell/taste:Nose examination:

II External examination of eye: - Visual Acuity:- Visual fields by confrontation:

Pupillary light reflexes = Direct:= Consensual:

Fundoscopy findings:

III Ocular Muscles:Eye opening strength:

IV Inferior and Medial movement of eye:

V a. Sensory - Ophthalmic:- Maxillary:- Mandibular:

b. Motor - Masseter:- Jaw lateral movement:

c. Reflexes - Corneal reflex- Jaw jerk

VI Lateral movement of eyes

VII a. Motor - Raise eyebrows:- Frown:- Close eyes against resistance:- Show teeth:- Blowout cheeks:

Taste - Anterior two-thirds of tongue:b.

VIII Gen.eral Hearing:Rinnes = L: R:Webers lateralisation:Vestibular function - Nystagmus:

- Rombergs:- Wallenbergs:

Otoscope examination:

IX & Gag reflex:X Uvula deviation:

Speech quality:

XI Shoulder lift: .S.C.M. strength:

XII Inspection of tongue (deviation):

Motor System:

a. Power- Shoulder

- Elbow- Wrist

= Abduction & Adduction:= Flexion & Extension:= Flexion & Extension:= Flexion & Extension:

- Forearm- Fingers- Thumb- Hip

- Knee- Foot

b. Tone

c. Reflexes

Sensory System:

a. Dermatomes

= Supination & Pronation:= Extension (Interphalangeals & M.e.p's):= Opposition: .= Flexion & Extension:= Adduction & Abduction:= Flexion & Extension:= Dorsiflexion & Plantar flexion:.= Inversion & Eversion:= Toe (Plantarflexion & Dorsiflexion):

- Shoulder:- Elbow:- Wrist:- Lower limb - Int. & Ext. rotation:- Knee clonus:- ankle clonus:

- Biceps:- Triceps:- Supinator:- Knee:- Ankle:- Abdominal:- Plantar:

- Light touch:- Crude touch:- Pain:- Temperature:- Two point discrimination:

b. Joint position sense - Finger:- Toe:

c. Vibration:

Cerebellar function:

- Big toe:- Tibial tuberosity:-ASIS:- Interphalan.geal Joint:- Sternum:

Obvious signs of cerebellar dysfunction:= Intention Tremor:= Nystagmus:= Truncal Ataxia:

Finger-nose test (Dysmetria):Rapid alternating movements (Dysdiadochokinesia):Heel-shin test:Heel-toe gait:Reflexes:Signs of Parkinsons:

8. SPINAL EXAMINATION:(See Regional examination)

Obvious Abnormalities:Spinous Percussion:R.O.M:Other:

9. BREAST EXAMINATION:

Summon female chaperon.

Inspection - Hands rested in lap:- Hands pressed on hips:- Arms above head:- Leaning forward:

Palpation - masses:- tenderness:.- axillary tail:- nipple:- regional lymph nodes:

App~ndi~ G

REGIONAL EXAMINATION - THORACIC SPINE

Patient: ----------------------------- File #: ----- Date: ----furem: _ Signature: _

Clinician: -------------------- Signature: _

STANDINGPosture (incl. LIS & CIS):Muscle Tone:Skyline view - ScoliosisSpinous PercussionBreathing (quality, rate, rhythm, effort):Deep inspiration

Scars:Chest Deformity(pigeon, funnel,barrel):

RANGE OF MOTIONForward flexionExtensionLlR RotationL/R Lateral Flexion

20 - 45 degrees (15cm from floor)25 - 45 degrees35 - 50 degrees20 - 40 degrees

~

( \.:I '

left rot right rot

left lat flex -----.-r---- right lat flexfo/~...,.,

extension

RESISTED ISOMETRIC MOVEMENTS: (in neutral)Forward flexion ExtensionLlR Rotation LIR Lateral Flexion

SEATED:Palpate Auxillary Lymph NodesPalpate Ant/Post Chest WallCostovertabral Expansion (3 - 7cm diff. at 4th intercostal space)Slump Test (dural stretch test)

SUPINE:Rib MotionSoto Hall Test (#, sprains)

SLRPalpate Abdomen

PRONE:Passive Scapular ApproximationFacet Joint ChallengeVertebral Pressure (P-A central, unilateral, transverse)Active Myofascial Trigger Points:

Rhomboid MajorLower TrapeziusSerratus PosteriorPectoralis MajorQuadratus Lumborum

Rhomboid MinorSpinalis ThoracicSerratus SuperiorPectoralis Minor

CO~NTS: __

NEUROLOGICAL EXAMINATION' .DERMATOMES I

Tl T2 T3 T4 TS T6 T7 T8 T9 TIO TIl Tl2

Left

Right

Reflexes:Basic LOWER LTI\1B neuro:

Dermatomes :Myotomes:

KEMPS TEST:

MOTION PALPATION:

Bucket handle:

Left:Right:Joint Play:Left:Right:Joint Play:Left:Right:

Ribs: Calliper:

Motion Palpation:and Joint Play

Basic Lumbar Exam:History:ROM:Neuro/Ortho:

Basic Cervical Exam:HistoryROM:Neuro/ortho:

Appendix H

Date: _ Fine no:------- Visit no:-----

Patient name: -------------------------

Please indicate on the line below, the number between 0 and 100 that best describes

the pain you experience when it is at its worst. A zero (0) would mean "no pain at

all", and one hundred (100) would mean "pain as bad as it could be".

Please write only one number.

Please indicate on the line below, the number between 0 and 100 that best describes

the pain you experience wlnen it is at its least. A zero (0) would mean "no pain

at all" and one hundred (100) would mean "pain as bad as it could be".

Please write only one number.

OSWESTRY BACK ][)ISAB~ITY INDEX

Patient Name: _

Appendix I

File no: Date _

mus questionnaire has been designed to give the doctor information as to how your back pain has affected your ability to manage everydayife. Please answer every section and mark in each section only ONE box as it applies to you. We realize you may consider that two of the~tements in anyone section could relate to you, but please just mark the box which most closely describes your problem.

Section 1 - Pain Intensitv Section 6 - Standing

oooooo

I have no pain at the moment.The pain is very mild at the moment.The pain is moderate at the moment.The pain is fairly severe at the momentThe pain is very severe at the moment.The pain is the worst imaginable at the moment.

[]ooooo

I can stand as long as I want without extra pain.I can stand as long as I want, but it gives extra pain.Pain prevents me from standing for more than 1 hour.Pain prevents me from standing for more than 'l'2 hour.Pain prevents me from standing for more than 10 minutes.Pain prevents me from standing at all.

Section 2 - Personal Care (Washing, Dressing ...) Section 7 - Sex life

o I can look after myself normally without causing extra 0pain. 0I can look after myself normally but it causes extra pain.. 0It is painful to look after myself and I am slow and 0careful. 0I need some help but manage most of my personal care. 0I need help every day in most aspects of self careI do not get dressed, I wash with difficulty and stay inbed.

ooooo

My sex life is normal and causes no extra pain.My sex life is normal but causes extra pain.My sex life is nearly normal but it is very painful.My sex life is severely restricted by pain.My sex life is absent because of pain.Pain prevents any sex life at all.

Section 3 - Lifting Section 8 - Social life

ooo

I can lift heavy weights without extra pain. 0I can lift heavy weights but it gives extra pain. 0Pain prevents me from lifting heavy weights off the floor, 0but I can manage if they are conveniently positioned, forexample on a table.Pain prevents me from lifting heavy weights, but I can 0manage light to medium weights if they are convenientlypositioned . z; 0I can lift only very light weights~""" 0I cannot lift or carry anything at alL

o

oo

My social life is normal and gives no extra pain.My social life is normal but increases the degree of pain.Pain has no significant effect on my social life apart fromlimiting my more energetic interests, for example:dancing.Pain has restricted my social life and I do not go out asoften.Pain has restricted my social life to my home.I have no social life because of pain.

Section 4 - Walking Section 9 - Sleeping

oooooo

Pain does not prevent me walking any distance.Pain prevents me walking more than 1 mile (2.2lan).Pain prevents me walking more than 'l'2 mile (l.Ikm).Pain prevents me walking more than 1/4 mile (O.5lan).I can only walk using a stick or crutches.I am in bed most of the time and have to crawl to thetoilet.

oooooo

I have no trouble sleeping.I can sleep well only by using pills.Even when I take pills I have less than 6 hours sleep.Even when I take pills I have less than 4 hours sleep.Even when I take pills I have less than 2 hours sleep.Pain prevents me from sleeping at all.

Section 5 - Sitting Section 10 - Traveling

Adapted from Fairbanks (1980)

I can sit in any chair as long as I like.I can only sit in my favorite chair as long as I like.Pain prevents me sitting for more than 1 hour.Pain prevents me from sitting for more than ~ hour.Pain prevents me from sitting for more than 10 minutes.Pain prevents me from sitting at all.

oooooo

oooooo

I can travel anywhere without extra pain.I can travel anywhere but it gives extra pain.Pain is bad but I manage trips over 2 hours.Pain restricts me to trips less than 1 hour.Pain restricts me to trips under 30 minutes.Pain prevents me from traveling, except to the doctor and /or hospital.

Appendix J

SInOIr1t- ifOIrlI1ill M<e<GJilln JPallllID Qunes1tJiOIID.lID31JiIre (SJF-MJPQ)Ronald Melzack (1984)

Date: File no.: _ Visit no:---

Patient name:--------------------------

,

: :.:

r\:,·: . . " ..- _., ,.. " .. :·:·::·sHdoTfNG·: >:.: .••••...••,.... . , .

STABBING > ..".-. :.....:.:: ~~,~ .... ":....::.. i '-"~ :::..':"::::.:.:: : :.:...••• :..• :::::: .; ":.:"':'.,,:.. :...::':::::.:.:.c:.: .':.::::..c.:..: ..:.:.::'::.:'••:

............. , .

.•••.:··:••··.":·.fï,of2BU~ING·····:t;·1,;.-:_ ,.~::::.::::,.: .. ::::::::':::~::::::;:::.:.::::. : :.: ,-. , .

... ,:.:.,: .... ::::.,;''';::: :::::::::::::~::::~:::::::.:::::::~:::::i::::::::::;::::::~::::::::: ::.:.:::.::,:,:.

·$IRlNG;:ExHAt1SmING:···· ••'·

::::: .. :::.:: :.:.:: :.::: : .. :'. :':':i:::::·: .:~::i:::·:·::::::;::~:::~::::;::...... . 0'0'"'' ~.• ,.,t: P:UNISHING::CRuet":':. _.. ...... ::.:.. ." ... .... .. .._.:.:' :':':' .....:.:' ~:,.-.. . .

Adapted from the Short-fomt McGill Pain Questionnaire. Copyright 1984 Ronald Melzacl<

NAME Appendix K

FILE NO = _

GROUP = _

Flexion

Extension

Right Rotation

Left Rotation

Right Lateral Flexion

Left Lateral Flexion

MP finding

MANliJP>1UILATlI ON J[}Al'A

Adj.Technic

Scheduling Status ~Proprietary name (and dosage lorm)

Cataflam® D Dispersiblelal~~e~$CompositionOne CATAFLAM 0 Tablet contains 46.5 mg ol diclolenac lree acid.which is equivalent to 50 mg diclolenac sodium.Pharmacological classilicatiaaA 3.1 Antir1leumatics (anti-inflammatory agents)Pharmacological actionCATAFLAM D is a non-steroidal con:tpoun~ with antirt1eumati~. .anti-mflammatory. analgesic and antipyretic properties. In vitrO. itsactive substance strongly inhibits prostaglandin-synthetase and alsohas an inhiMory effect on platelet aggregation.Inhibition of prostaglandin biosynthesis. wIlich has been demonstratedexperimentally. is regarded as having an important bearing on itsmechanism of action. Prosta91andins playa major role in thecausation ol inflammation. pain and fever.PharmacokineticsAbsorption:Absorption of diclofenac from CATAFLAM D sets in rapidly afteradministration. The plasma concentrations show a linear relationshipto the size of the dose. Peak levels are attained in 20 to 60 minutesafter ingestion on an empty stomach.The active substance is subject to first-pass metabolism.Protein binding: 99.7 %The mean terminal elimination half-life of the unchanged drug is Ito 2hours.Excretion:Approximately 60 % of the dose administered is excreted via tilekidneys in the form of metabolites and less than 1 % in the unchangedtorm, About 30 % of the dose is excreted in metabolised form in tilefaeces.ladicationsAs sncrt-ierm treatment in tile following acute conditions:Flare-up of osteoartllrosis.Painful musculoskeletal conditions.Non-articular rt1eumatism.Acute attacks of gout.Painful post-operative and post-traumatic inflammation and swelling.pain following dental surgery.

.,symptomatic treatment for primary dysmenorrtloea.Contra-indicationsGastric or intestinal ulcer. Allergy to tile active substance. CATAFLAMD is also contra-indicated in aSthmatic patients in whom attacks ofaSthma. urticaria. or acute rt1initis are precipitated by acetylsalicylicacid or by other medicines with prostaglandin-synthetase Inhibiting

Ë~l.AM D should not be used in patients with porphyria.Pregnancy.CATAFLAM D is not suitable for use in children under 14 years of age.WamiagsIt should be noted that only shOlt-term treatment is recommended withCATAR..AM D.Strict accuracy of diagnosis and close medical surveillance areimperative in patients with symptoms indicative ol gastro-intestinaldisease. a case history suggestive ol gastro-intestinal ulceration.ulcerative colitis. Crohn's disease. in patients suffering from impairedhepatic function and pre-existing dyShaemopoiesis or disorders ofblood coagulation.CATAFLAM D should be administered with caution in patients withhepatic or renal failure.. .Serious interactions have been reported after tile concomitant use olmethotrexate and diclofenac.Dosage and directions lor useAdultsFor tile relief of acute pain. the tablets should prelerably be taken on anempty stomach. The tablets are dropped into. a gla~ of water and theliquid stirred to aid dispersion before swallOWing. Since a proportion ofthe active substance may remain in the glass after swallowing. it isadvisable to rinse the glass with a small amount of water and 10swallow again.As a rule. the initial daily dosage is 2 to 3 CATAFLAM D tablets. Inmilder cases. 2 CATAFLAM D tablets daily are usually sufficientThe maximum daily dose is 3 CATAFLAM D tablets.The daily dosage should generally be prescribed in two 10 threefractional doses.In primary dysmenorTtloea the daily dosage. which should beindividually adapted. is Ito 3 CATAFLAM D tablets. Treatment shouldbe started upon appearance of tile first symptoms and. depending ontheir intensity. continued for a few days.Side-effects and special precautionsGastro-intestinal tractMore frequently: Epigastric pain. nausea. vomiting. diarrhoea.abdominal cramps. dyspepsia. flatulence. eructation. anorexia. localirritation.Less frequently: Gastro-intestinal bleeding may occur. haematemesis •.melaena. bloody diarTtloea. gastric or intestinal ulcer with or withoutbleeding or perforation. . ..Lower gut disorders such as non-specific haemorrt1aglc colitis andexacerbation of ulcerative colitis or Crohn's proctocolitis. aphthousstomatitis. glossitis. oesophageal lesions. diaphragm-like intestinalstrictures. constipation and pancreatitis.Central Nervous SystemMore frequently: Headache. dizziness. vertigo and nervousness.Less frequently: Tiredness. ~isturban.ces .of sensati~n (includingparaesthesia) and memory. disonentation. Insomma. irritability,convulsions. depression. anxiety. niglTtmares. tremor. psychoticreactions. aseptic meningitis.Special sensesLess frequen~y: Disturbances of vision (blurred vision. diplopia).impaired hearing. tinnitus. taste alteration disorders.SkinMore frequently: Rash and skin reactions.Less frequently: Urticaria. Bullous eruptions. eczema. erythema

multiforme. Stevens-Johnson syndrome. Lyell's syndrome (acute toxicepidermolysis). erythroderma (exfoliative dermatitiS). loss of hair.photosensitivity reaction. purpura including allergic purpura.Kidney .Less frequen~y: Oedema. acute renal failure. urinary abnormalitiessuch as haematuria. proteinuria. interstitial nephritis. nephroticsyndrome. papillary necrosis.UverMore frequently: Elevated transaminase levels (SGOT. SGPT).Less frequently: Hepatitis with or witllout jaundice. Fulminanthepatitis.BloodLess frequently: Dyshaemopoiesis (leucopenia. tIlrombocytopenia.aplastic anaemia. haematolytic anaemia and agranulocytosis).HypersensitivityLess frequently: Allergic reactions (eg bronchospasm. anaphylactic /anaphylactoid systemic reactions including hypotension).Vasculitis. pneumonitis.Cardiovascular systemLess frequently: Palpitation. chest pain. hypertension. congestive heartfailure.PrecautionsGastro-intestinal bleeding or ulcerations / perforations can occur at anytime during treatment. with or without warning symptoms or a previOUShistory. The elderly must receive close monitoring. Dosage may haveto be reduced in tile elderly. In particular it is recommended that thelowest effective dosage be used in frail. elderly patients or those with alow body mass. .In tile instances where peptic ulceration or gastro-intestinal bleedingoccur in patients under treatment with CATAFLAM D. the medicineshould be withdrawn.In view of the product's inherent potential to cause fluid retention. heartfailure may be precipitated in some compromiSed patients.Owing to the importance of prostaglandins for maintaining renal bloodflow. patients suffering trom impairment of hepatic. cardiac or renalfunction. as well as the elderly. patients being treated with diuretics andthose with extracellular volume depletion trom any cause. eg tile peri-or post-operative phase of major surgical operations. should becarefully monitored.Elevation of one or more liver enzymes may occur with CATAFLAM D.During prolonged treatment with CATAFLAM O. blood counts andmonitoring of hepatic and renal function are indicated.If abnormal liver function tests persist or worsen. il clinical signs orsymptoms consistent with liver disease develop. or if othermanifestations occur (eg eosinophilia. rash. etc). CATAFLAM D shouldbe discontinued. Hepatitis may occur without prodromal symplOms.Caution is called for wilen using CATAFLAM D in patients with hepaticporphyria. since CATAFlAM 0 may trigger an attack .Allergic reactions. including anaphylactic / anaphylactoid reactions. canalso occur without earlier exposure to the medicine.CATAFLAM D may mask the signs and symptoms of infection due to itspharmacodynamic properties.Patients experiencing dizziness or other central nervous disturbancesshould refrain from driving a vehicle or operating machines.InteractionsWhen given together with preparations containing lithium or digoxin.CATAFLAM D may raise their plasma concentrations.Concomitant administration of glucocorticoids or other non-steroidalanti-inflammatory agents. may aggravate gastro-intestinaJ side-effects.Concurrent treatment with two or more non-steroidal anti-inflammatoryagents may promote the occurrence of side-effects.The bioavailability of CATAFlAM 0 is reduced by acetylsalicyfic acid.and that ol acetylsalicyfic acid by CATAFLAM O. when tile two agentsare administered together.There are reports ol an increased risk ol haemorrtlage with thecombined use ol diclolenac and anticoagulant therapy. Thereforeclose monitoring of such patients is recommended.Both hypoglycaemic and Itypergtycaemic effects in the presence ofCATAFLAM D which necessitated changes in the dosage ofhypoglycaemic agents have been reported.Increased nephrotoxicity of cyclosporin may occur through effects ofCATAfLAM D on renal prostaglandinS.There have been isolated reportS ol convulsions which may have beendue to concomitant use ol quinolones and NSAIOs.LactationFollowing oral doses of 100 mg daily. no active substance could befound in the breast milk (fimit of detection: 10 nwml) .I(not711 symptoms of overdosage alld particalars ol itstreatmentSee side-effects and special precautions.TreatmentThere is no specific antidote. Symptomatic and general supportivemeasures.Supportive and symptomatic treatment should be given lorcomplications such as hypotension. renal failure. convulsions.gastro-intestinal irritation and respiratory depression.Specific therapies such as lorced diuresis. dialysis. or llaemoperlusionare probably of no help in eliminating CATAFlAM 0 because ol its highprotein-binding rate and extensive metabolism.Absorption !rom tablets should be prevented as soon as possible alterthe overdosage by means of gastric lavage and treatment withactivated charcoal.IdentificationWhite. flat. triangular tablets with bevelled edges. One side bears tileimprint CG. tile other side a raised V. Width. measured !rom flattenedvertex: approximately 9 mm. Thickness: approximately 3.9 mm.PresentallanCATAFLAM D is supplied in packs 0115 tablets.Storage instructionsStore belo~ 25 "C and protect !rom moisture.Keep out of the reach ol children.Registration number2B/3.1/0306Name and business address ol lI1e applicantNOVARTlS SOUTH AFRICA (Ply) Ltd72 Steel RoadSpartanKempton Park. 1619Date ol publication ol this package insert 03/12/1993eRegistered Trade Mark 55760

Appendix L

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Appendix M